Director, QualityMerrimack Manufacturing • Manchester, NH, US
Director, Quality
Merrimack Manufacturing • Manchester, NH, US
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[job_card.job_description]This position will help establish, mentor and lead our Quality Team. This position will be the lead role for the Quality Team and will be the cornerstone for further developing this function. This role will report directly to the General Manager at Merrimack Manufacturing, and will be a key conduit to both the manufacturer of record and the design authority for the products we manufacture. Improve and maintain a quality assurance system that ensures customer safety is never compromised Develop, implement, manage and continuously improve a 21 CFR 820 quality management system (QMS) Attain and maintain ISO 13485 : 2016 certification Serve as Merrimack Manufacturing’s Management Representative and serve as the primary interface on all audits Act as the primary contact with customers regarding quality issues or complaints and drive the response process Establish and lead a quality assurance team that focuses on external and internal customer service Provide daily guidance and leadership to supplier quality engineers and incoming inspection personnel Oversee the training of all employees related to their role within the QMS Serve as the primary quality control resource for problem identification, resolution, loss reporting, and continuous improvement Oversee MRB and NCR activities and provide feedback on root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements Support concurrent engineering efforts by participating in design development projects representing quality assurance at Merrimack Manufacturing Working closely with the supply chain team, establish and maintain a process for monitoring supplier performance and help drive overall supplier performance and quality Working in concert with Operations and Engineering, establish and implement metrics for monitoring the QMS effectiveness and to enable managers to make sound product quality decisions Continually look for opportunities to improve processes and business tools to allow us to more efficiently and effectively manage our company QUALIFICATIONS AND SKILLS : 15+ years of experience with QMS implementation and management 10+ years of experience working in the medical device industry Experience with Quality Management System (ISO 13485), Medical Device Regulations (21 CFR 820) and applicable regulatory requirements and standards Demonstrated experience leading teams through FDA inspections Must be able to communicate quality guidance appropriately and adequately to all levels and roles Strong knowledge of regulatory and quality requirements meshed with common sense approaches Experience with ERP and PLM systems and utilizing them within a QMS Team player who prefers to take a collaborative approach in problem solving Intellectually curious and not afraid to delve into various operational processes Experienced leading teams Experienced working in a startup environment is a plus EDUCATION : Bachelor’s degree or equivalent number of years of experience. Powered by JazzHR
COMPANY OVERVIEW :
- Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard.
- We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.
POSITION OVERVIEW :
RESPONSIBILITIES :
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