Quality Systems Manager
Puritan Medical Products is hiring for a QUALITY SYSTEMS MANAGER to join their team saving the world, one swab at a time, at their new manufacturing facility in Pittsfield, ME. Join Puritan in the quest to get testing supplies to the professionals!
A family-owned business for over 100 years, Puritan offers a comprehensive benefits plan, the opportunity to advance, and a warm and friendly employee-centric atmosphere. Benefits are available to employees working 32 hours per week and include medical, dental, and vision insurance, as well as employee and dependent term life insurance.
We are looking for candidates who bring a cooperative spirit, welcome the opportunity to learn, and take pride in a job well done.
The Quality Systems Manager reports directly to the Director of Regulatory Affairs and Quality Assurance. This is a full-time exempt position with hours which are necessary to accomplish the goals and deliverables of the Quality Department. The QS Manager accomplishes their duties by doing the following:
- Work directly with production supervisors to resolve in-process quality issues and make decisions with regard to current production non-conformances.
- Work directly with Director of Regulatory Affairs on CFE Investigations:
- Investigate root cause of defect and implementation corrective actions with production management and Regulatory/QS.
- Initiate employee discussions related to CFE’s and in-process NCR’s (day and night shifts)
- In Process Non-Conformances
- Make acceptance or rejection decisions on in-process non-conformances of finished goods.
- Include Regulatory/QS and Production management in decision making process when appropriate.
- Work directly with Purchasing on incoming inspection material non-conformances or in-process raw material non-conformances.
- Oversee all Quality Group personnel.
- Manage regular work and overtime schedules for QC inspectors.
- Assist Director of Regulatory Affairs in the planning, hosting, coordinating of audits performed by BSI, global customers and regulatory agencies (US and Foreign).
- Follow-up on action items and CAPAs that arise from routine client, regulatory audits or other quality issues that arise to ensure appropriate and timely escalation, CAPAs and closure.
- Lead quality assurance team meetings each day, both shifts.
- Implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final acceptance activities.
- Maintain a working knowledge of ISO 13485:2016 requirements.
- Sign-off of all sterile release loads and production batch records.
Key Skills Required
- Great documentation, writing, and communication skills
- Problem solving and conflict resolution skills
- Able to perform duties with minimal direction and supervision
- Able to develop and lead a team
- 5 years of Manufacturing Quality Management experience
- Proven track record of and managing and meeting Quality Systems goals
- Intermediate mathematics (addition, subtraction, multiplication, and division)
- Able to lift 30 lbs.
This position pays $21.00 per hour. All offers are contingent upon successful completion of a pre-employment physical. Subject to DOT regulations offers might also be contingent on successfully completing drug testing.
NO PHONE CALLS OR RECRUITERS PLEASE
Puritan Medical Products is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, credit history, unemployment status, or veteran status.
KMA Human Resources Consulting is a Maine-based company that handles recruiting and human resources for its clients. They are working with Puritan to hire the future workforce that will be manufacturing swabs at our new location in Pittsfield. KMA is proud to partner with Puritan to provide full-service recruiting support during this period of fast growth at Puritan. Applications for Pittsfield positions will be reviewed by KMA and they will work closely with Puritan to move candidates through the interview process.