At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
+ Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
+ Provide direction and training to other staff members performing duties in the microbiology area.
+ Develop, validate and maintain sterilization systems for Integer products. Conduct sterile validations and adoptions for new products. Coordinate and train staff to assure that all functions involved in completing the production sterile runs are carried out.
+ Develop and perform testing to ensure product safety and meet biocompatibility requirements of FDA, ISO, Japanese Ministry of Health and other regulatory agencies.
+ Develop and coordinate the cleanliness and contamination control programs for Integer manufacturing areas. Coordinate environmental monitoring on all cleanrooms. Provide training and guidance on regulations for cleanroom operations. Provide guidance on water quality management.
+ Select and audit contract sterilizer and testing laboratories.
+ Primary customer and regulatory body contact on sterilization, cleanliness policies and biocompatibility issues.
+ Complete protocols, final reports, and validations related to sterilization, biocompatibility and environmental monitoring.
+ Provide guidance and leadership to product development, production and product transfer teams on biocompatibility and sterilization requirements, as well as environmental impacts of new product introductions and production line layout changes.
+ Apply continuous improvement/lean concepts to identify and eliminate non-valued added tasks and/or activities.
+ Apply problem solving methodologies 8D, PDCA, DMAIC to identify root cause and create and implement corrective and preventive actions.
+ Performs other duties as required.
+ Knowledge & Skills:Special Skills:
+ Ability to apply advanced skills in microbiology and develop new methods to solve complex problems.
+ Ability to exercise independent judgement in developing methods, techniques and evaluation criteria
+ Skilled in multi-tasking and prioritizing.
+ Excellent written and verbal communication skills. Good presentation skills.
+ Specialized Knowledge:
+ General knowledge of GLP, GMP and QSR.
+ Working Knowledge of Medical Device Regulatory requirements including FDA, ISO and PMDA Ministry of Health (Japan).
+ Knowledge of scientific theories and methods pertaining to bioburden, LAL and water testing. Ability to interpret relation of bacterial identifications.
+ Knowledge of the methods of biocompatibility testing and the ability to interpret the data in relationship to current industry guidance.
+ Knowledge of EO sterilization process and requirements to validate and maintain a sterile cycle.
+ Other: Physical demands include equal amounts of sitting, standing and walking (including stairs and between buildings). High level of computer keyboard typing and computer screen viewing. Lift boxes up to 40 lbs. Use problem-solving techniques, high degree of attention to detail, work effectively on teams and communicate effectively with and lead people inside and outside the department.
+ Education & Experience:Minimum Education: Bachelor’s degree in one or more of the following disciplines: Biology (Biological Sciences), Microbiology, Molecular Cell Biology (MCB), Biochemistry or Chemistry. Alternatively two years of experience in a related field may be substituted for every year of education. Minimum Experience:
+ Five (5) to eight (8) years experience in the medical device manufacturing industry and at least (3) years’ experience in microbiology.
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at