Integer Senior Quality Systems Engineer in Wilmington, Massachusetts
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!
Do you have a passion for quality systems?
Are you looking to join one of the top medical device quality organizations?
Are you a natural problem solver?
If you answered yes, we’d love to speak with you. Integer is hiring for a Senior Quality Systems Engineer.
Accountabilities & Responsibilities:
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.
Leads the execution and improvement of quality assurance and quality systems activities.
Develops and manages quality systems that comply with national and global regulatory requirements.
May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.
Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
Provides management with technical guidance as required.
Identifies and procures the appropriate process equipment.
Investigates, develops and implements new process technologies of major scope.
Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
Subject matter expert in engineering specialty/application.
Performs other duties as required.
Minimum Education & Experience:
Bachelor's degree required (technical discipline preferred)
7+ years Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics industry
Specialized Knowledge: Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.
Special Skills: Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.
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