Job Title: Quality Manager - Medical Device Manufacturing
Location: Shelton, CT
JOB SUMMARY / ESSENTIAL DUTIES & RESPONSIBILITIES
- Leads the Quality Group as a Management
- Coordinates Quality Assurance with QA Engineering and QC
- Coordinates Quality Control with QC Engineering and QA
- Establishes and approves the Quality Policy along with the
- Ensures company compliance with current or proposed ISO
- Reviews and approves the Quality
- Oversees Internal Quality Audits and External Quality
- Chairs management reviews per SOP's to achieve;
- Risk Management and
- Company level data
- Liaison with customers regarding satisfaction and compliance including;
- Nonconformances and concessions requiring Customer
- Liaison with customer for resolution of quality
- Quality SCR's (Supplier Change Requests).
- Leads the Quality Group duringESI,APQP,PPAP's, to achieve;
- Prototype development and
- Quality Control Planning and
- Capability studies and Gage R & R's.
- First Article
- Leads the Quality Group to ensure;
- Receiving, Set-up, in-process and final
- Training of inspection personnel as
- Training of all employees is
- Corrective Action program (Internal and External).
- Statistical Analysis program
- Manufacturing SCR's are
- Responsible for the maintenance and control of the Approved Supplier
EDUCATION AND / OR EXPERIENCE
- ISO 9001:2015 / ISO 13485:2016 experience.
- Higher Education.
- Computer skills;
- Mini Tab statistical analysis.
- MS Office (Excel, MS Word).
- ERP Knowledge.
- CMM / VMM knowledge.
- Strong stamping/machining and/or manufacturing background.
- Mechanical inspection knowledge.
- Qualification procedures as in PPAP, APQP, PMA, Vendor/Supplier approvals.
LANGUAGE SKILLS: Read, Write, speak and comprehend Basic English.
MATH SKILLS: Exceptional.
REASONING ABILITY: Better than average. Can make appropriate decisions and can apply appropriate techniques.
WORK ENVIRONMENT: Office Environment, QA Lab, shop floor.
COMPETENCY: Competency is reached when the employee is able to:
- Meet quality objectives established by the Company.
- Is able to obtain or maintain ISO registrations.
- Is able to increase department productivity level and accountability for quality goals and objectives.
Monroe Staffing Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, color, Religion, gender, disability, veteran status, sexual orientation, gender identity, national origin or other protected classification.