Integer Quality Systems Specialist 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!
The primary purpose of this position is to support several key processes within the Quality Management System to assure compliance to applicable standards. The incumbent will provide a significant portion of the data needed to maintain the Quality Management System and also contribute to the business performance metrics. The incumbent will be responsible for representing the Company in a professional and exemplary manner before our suppliers, Associates, and community.
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.
Implements controls for the Integer Quality Management System (QMS) and product documentation, External Standards, and customer-required specifications. Develops and maintains database systems to support the QMS.
Maintains quality records, administers and records change history, and implements approved QMS changes.
Controls obsolete documentation, including disposition of discontinued or inactive documentation.
Handles design and development history records, including product and design transfers.
Corrective and Preventive Action (CAPA):
Documents and updates CAPA information related to customer complaints.
Initiates, tracks, and reports on CAPA status in the current company-wide system to effect change.
Administers correspondence related to registrations, certifications, and required files and listings related to Integer quality systems, product status and procedures.customers of updates to quality system status (new site, new certificates, etc.).
Assists with customer inquiries related to quality agreements and the QMS.
Generates periodic reports on quality system metrics including specific to enterprise metrics and summaries of common facility performance metrics.
Performs other duties as required.
Education & Experience:
- Minimum Education: High school diploma or GED required. Associate degree or certification in business or
Minimum Experience: 3+ years of experience with documented training in AS9100 / ISO13485 / FDA QSR
systems will qualify in lieu of technical degree
Knowledge & Skills:
- Special Skills: Experience with MS-Word, Excel, Access and Power Point. Good communication skills. Must
be able to balance multiple priorities. Maintain organization of quality system procedures.
- Specialized Knowledge: Oracle and Pro-Engineer experience preferred.
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, gender, and gender nonconformity), 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