Summary:
A QA Specialist for Medical Device Combination Product is required for a biotech in West Dublin. The successful candidate will provide quality oversight and support for clinical and commercial devices and combination products from introduction throughout the product and design control lifecycle and the associated Quality System. As a significant quality contributor, the incumbent will proactively engage with all stakeholders involved with supplier quality agreements, device and combination product batch release, risk management and QMS audit preparation during technology transfer and commercial operations.
Responsibilities:

• Responsible for documenting and periodic review of supplier quality requirements and supplier quality agreements.
• Responsible for the review and approval of batch release for combination products.
• Ability to identify non-conforming batch results or trends and escalate them via the Quality Management System.
• Support risk assessments relating to batch release or product quality for clinical and commercial products.
• Ensure timely entry, processing, and closure of quality records in compliance with procedures.
• Support the review of Design Control deliverables including Risk Management activities.
• Responsible for coordination & documentation of the Change Control Review Board for Medical Device Changes.
• Support the development of the QMS as it pertains to Medical Devices and Combination Products to achieve the ISO 13485 standard and compliance with 21CFRPart4 and the medical device regulation 2017/745.
• This will involve supporting quality input to the implementation to the QMS, reviewing new SOPs, mock audits, internal audits and updates to SOPs.
• Support internal audit activity from coordination, preparation and execution to improve the QMS and support stakeholders in adherence to the QMS.
• Supports Notified Body and Health Authority inspections and compliance.

Qualifications & Experience:

• Minimum of a B.Sc. degree in biological /chemical sciences, biomedical/mechanical engineering, or other related subject.
• Minimum of 4+ years’ experience in Quality with medical device or combination products in a regulated environment.
• Risk Management Standard for Medical Devices ISO 14971 2019.
• Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
• Familiarity with SAP and Trackwise would be desirable.

• Manage the delivery of engineering support to all manufacturing operations on-site impacting product availability.
• Coordinate the resolution of any technical issues arising in the manufacturing process, running diagnostics and delivering solutions to the business.
• Lead cross-functional project teams working on new product introductions and technology transfers as required.
• Compile and review technical reports including verification, validation of product and process changes, risk assessment, equipment commissioning, deviations, corrective and preventative actions documents.
• Drive projects & tasks to meet business needs with a focus on customer requirements.
• Participate in new product developments by providing design for manufacture guidance and support.
• Define and lead design of product enhancements and validation of design changes.
• Lead the multi-disciplinary team to design solutions for products and process across the product portfolio (mechanical, electronic, electrical, or software).

• You will be Degree qualified (level 8) in a technical discipline - electronic, mechanical or manufacturing engineering.
• A minimum of 7 years' experience in a highly regulated manufacturing environment.
• Proven leadership and management skills.
• Strong analytical and problem-solving capability where you have previously designed successful solutions to production outages and customer issues.
• Core understanding of validation processes and quality standards.

• Salary €65,000 - €70,000
• Annual performance bonus
• Full family healthcare plan
• Contributory pension scheme
• Education assistance
• Subsidised canteen
• Flexible working hours
• Active sports and social club
• 23 days annual leave

Senior Embedded Engineer (C++) - R&D Medical Devices - Dublin South

My client based in Dublin South is a world leading firm in the area of wearable technology and has engaged IT Search to speak to candidates regarding this challenging senior role that will work within R&D to create complex medical devices.

The role is to join an existing global team headquartered here as a Senior team member, mentoring more junior staff but bringing significant expertise to the R&D team in the areas of designing, testing and implementing embedded processes at all levels of the architecture. Working within compliance and regulatory guidelines, this role will allow the Senior Engineer to produce cutting edge technological solutions to the medical community.

This will be a hybrid onsite/remote role so candidates will need to be based within a commuting distance.

Candidates should have:

• 10+ years of commercial development experience using Embedded C++ post graduation, ideally within a pharmaceutical or highly regulated environment
• Microcontroller expertise alongside Assembly, RTOS and debugging
• Exceptional communications skills, able to work with multiple areas of the business and various locations and have a track record of strong documentation

To learn more about the role, client and process, please forward your CV stating required salary and availability and we can arrange a discussion.

Please note, we can only accept applications from candidates eligible to work in the EU

• Reporting into the Senior Program Manager you will work closely with a team of design engineers, internal manufacturing group and the contract manufacturing partner.
• You will manage the full project from cradle to grave and have resources allocated as required to the project work.
• Oversee change control processes both internally and with the contract manufacturing business.
• Interface with the device development team, internal manufacturing operations groups and the on-site manufacturing team.
• Support less experienced team members through sharing technical knowledge and expertise.

• Applicants must have a 3^rd level Degree in a technical discipline. A project management or LSS certification is highly advantageous.
• Minimum of 5 years' experience is required within a design position preferably within the medical device sector.
• Excellent communication skills required to work with cross-functional teams.
• Highly motivated individual who is self-managing and has a passion for invention.
• Working knowledge of Solidworks, Pro-Engineer, CAD-3D OR Inventor is a minimum expectation with proven ability to manage a project through the full design life cycle.

• Reporting into the Senior Program Manager you will work closely with a team of design engineers and internal manufacturing group.
• You will manage the full project from cradle to grave and have resources allocated as required to complete phases as required.
• Oversee change control processes both internally and with the contract manufacturing business.
• Interface with the device development team, internal manufacturing operations groups and the on-site manufacturing team.
• Support less experienced team members by sharing technical knowledge and expertise.

• Applicants must have a 3^rd level Degree in a technical discipline.
• Minimum of 8 years' experience is required leading design projects preferably within the medical device sector.
• Excellent communication skills required to work with cross-functional teams.
• A highly motivated individual who is self-managing and has a passion for invention.
• Working knowledge of Solidworks, Pro-Engineer, CAD-3D OR Inventor is a minimum expectation with proven ability to manage a project through the full design life cycle.

Job Responsibilities:

• Responsible for day to day activities designed to maintain and enhance the local Quality Management System for 3rd Party and Commercial oversight in line with directive 91/356/EEC, as amended by Directive 2003/94/EC, veterinary directive, Medical Device Directives, ISO13485 as applicable.
• The Quality Specialist will review and co-ordination of batch records and associated documentation including the generation of product release certificates to support batch release and certification of product.
• Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures
• Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, SOP’s.
• Interface between Regulatory Affairs, Marketing and Customer Service personnel where necessary.
• The Quality Specialist will be responsible for the writing, training and management of SOPs including associated training requirements
• Maintenance of system to ensure appropriate review and completion of Annual Product Quality Reviews
• Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required
• The Quality Specialist provide direct support during competent authority audits
• Assist in conducting internal self-inspections and external audits as appropriate
• The Quality Specialist will provide quality review and approval of artwork components where applicable

Job requirements

• Bachelor’s Degree required with a minimum of 3 years’ experience in QA/Compliance in pharmaceuticals or related industry.
• Prior pharmaceutical or quality assurance experience essential
• Strong analytical skills and knowledge of quality system essential
• Thorough knowledge of either EU GMPs and/or Medical Device Directives
• Computer literate essential including working knowledge of MRP system

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

• Ensure the vendors (manufacturers, distributors or other third party companies) have their Technical Agreements updated. 
• Support the Quality System Management to ensure the changes are aligned to the project and the other QMS tools.
• Support and document during the investigation of any non-conformance (Deviation Management System - CAPAs).
• Design, develop and implement Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
• Implication in the design and the generation of the verification process for EO sampling and attest of their compliance. 
• Excellent collaboration with the QA team onsite, they’ll also be there to support.
• Ensure alignment in all the SOP’s related to the EO processes. Review and update them accordingly. 
• Other elements of the MDR project as required.

• Ideally a level 7 Degree in a medical/scientific related field.
• Minimum 3 years’ experience in quality related or production in the pharmaceutical or medical device industry.
• Knowledge of the Quality System required for pharmaceutical and/or medical device industry.
• Previous documentation experience, ideally in a pharmaceutical or medical device company. 

• Enthusiasm and oriented towards Quality improvement.
• Excellent project management and administrative skills with good proficiency in Word, Excel and PowerPoint. 
• Excellent collaboration within the team but ability to manage own workload without supervision. 
• Manage the workload with flexibility in responding to urgent requests and operate according to agreed performance standards such as timelines.

Salary: Competitive (dependent on experience) excellent benefits

Location: Ireland, fully remote 

About the role

A Fishawack Medical Writer researches, writes, edits and prepares high-quality material for a variety of customised medical communications initiatives. A keen interest in medical science and writing, coupled with an ability to work to strict deadlines and specifications is essential.

Who are Fishawack Health?

Fishawack Health is the leading global commercialisation partner for the life science industry. Established in 2001 and headquartered in the UK, Fishawack Health is now an 800 strong global organisation, bringing together best-in-class agencies and experts across Medical Communications, Consulting, and Commercial.

We help develop, launch, and grow brands for clients across the life sciences industry, including global pharmaceutical and medical device manufacturers and emerging biotech and healthcare companies. Our internationally registered, award-winning teams collaborate across operations in the UK (Knutsford, Manchester, Brighton and Oxford) and USA (Evansville, New York, Philadelphia, Scottsdale, St. Louis and San Diego).

What you'll do

 As a Medical Writer you will be responsible for developing and delivering original, accurate, high-quality content (manuscripts, slides, and other editorial assignments) within the project specifications, timeline, and budget. This will involve:

• Liaising with clients, authors and colleagues to progress projects effectively,
• Attending congresses, symposia and advisory board meetings as required and liaising with speakers and clients
• Providing input on project specifications, costings and schedules, working with the internal account team to ensure projects are delivered to time and budget
• Providing good briefings to colleagues and freelancers
• Actively participating in account development meetings to grow repeat business
• Mentoring new writers (depending on individual, level of experience and opportunity)

About you

• Bachelor’s degree in the life sciences required; post-graduate qualification e.g. MSc, MPhil or PhD an advantage
• Previous experience in medical writing/publishing role and/or medical communications agency environment advantageous
• Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel
• Proficiency in Internet and PubMed searches
• Ability to work independently with minimal supervision, and as part of a team

What we offer 

We offer a creative, supportive environment with a uniquely diverse career structure where you will be able to continuously develop. Our STEPS training programme – Supporting Training, Enhancing Professional Development – provides a broad range of training delivered in-house and on-line, and supplements on-the-job training/project team-led training initiative, amongst other benefits.

Reasonable adjustments: We'll consider any reasonable adjustments you'd like us to put in place in the interests of fairness and equal opportunities.

We encourage all applicants to read our company Privacy Policy before applying to a role.

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Salary: £Competitive excellent benefits (bonus, healthcare, pension, life cover etc.) 

Location: Ireland, fully remote 

About the role 

As a Scientific Director/Senior Scientific Director you will be a scientific expert, providing insights and knowledge to projects, clients and new business efforts. You will review projects for strategic alignment and scientific accuracy, and when needed, act as the medical writer for more scientifically complex projects. Acting as a client relationship manager, you will build scientific credibility and partnerships, ensuring a high level of service with each client. You will provide scientific and strategic expertise to new business development activities, researching and developing content for pitches, as well as being part of the presentation team. Building a support network for junior members of the team, you will work closely with medical writers, account teams, client services and project management. In return, Fishawack will offer you excellent job benefits, on-going career opportunities and a supportive & flexible working environment.

Who are Fishawack Health? 

Fishawack Health is the leading global commercialisation partner for the modern life sciences era. Powered by a globe-spanning pack of strategic, creative, and scientific experts, we are driven to connect patients and healthcare professionals with the knowledge they need to live better lives.

Our three core operating units—Commercial, Consulting, and Medical Communications—can be leveraged individually but are designed for dynamic collaboration, with expert teams intentionally and uniquely assembled for each project. By bringing together best-in-class capabilities from around the world, we empower our clients—global pharmaceutical, medical device manufacturers, and emerging biotech and healthcare companies—to navigate the most complex of ecosystems while embarking on a faster, more efficient path to developing, launching, and growing their brands and portfolios.

Our internationally recognised, award-winning teams collaborate across operations in the UK (Brighton, London, Manchester, Knutsford, Dublin and Oxford) and USA (Evansville, New York, Philadelphia, Minneapolis, Scottsdale, St. Louis, and San Diego).

What you'll do

• Work closely with teams, leading the scientific development of projects
• Lead the development of scientifically complex materials as appropriate, proactively driving projects through to completion
• Combine in-depth scientific understanding of the product/therapy area with strong commercial awareness to inform all deliverables and communication planning recommendations
• Build and maintain relationships with clients, ensuring the highest level of service
• Participate in business development activities, such as pitching and proposals
• Provide leadership to ensure that teams are exceeding performance standards and developing professionally

About you 

• 5-10 years' experience in a medical communications agency environment, including medical writing experience and editorial management experience
• Bachelors degree in the life sciences; PharmD or PhD highly preferred
• Proficiency in the use of MS office, PowerPoint and Excel

What we offer 

We offer a creative, supportive environment with a uniquely diverse career structure where you will be able to continuously develop and tailor your career towards your preferred route, be that scientific delivery, operational, or client service. Our STEPS training programme – Supporting Training, Enhancing Professional Development – provides a broad range of training delivered in-house and on-line, and supplements on-the-job training/project team-led training initiatives. We also offer a generous company pension, private medical insurance plus many other excellent employee benefits.

We encourage all applicants to read our company Privacy Policy before applying to a role.

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