Director, Quality

Manchester, NH

Full Time

Quality Assurance

Experienced

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:
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.

RESPONSIBILITIES:

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.

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