ENTRY-LEVEL QUALITY ASSURANCE MANAGER - MEDICAL DEVICES
A trusted leader in injection molding within the medical devices space is looking for a Quality Assurance Manager to add to their growing team in the greater Madison, WI area. This is a direct-hire position and some relocation assistance will be considered for the right candidate.
Some of this organization's specialized expertise includes large part molding, ISO Class 8 clean room molding, thin wall plastic packaging, plastic injection molding of complex plastic parts and assemblies, metal to plastic conversions and contract manufacturing. This company's engineering expertise is one of the reasons why leading OEM's around the world turn to them as their custom plastic injection molder and manufacturing partner.
This company currently operates over 157 injection molding machines and a medical clean room facility across nine manufacturing sites located in the US, Mexico and China.
The Quality Assurance Manager will be responsible for the following:
- Coordinate ISO certification and customer audits as well as regulatory inspections, follow-up on reporting to agency, and coordination and implementation of corrective action plans with all departments.
- Develop and implement quality programs, meeting FDA, cGMP, and ICH guidelines for the manufacturing of medical device products.
- Conduct internal audits and audits of contract services
- Develop and control quality documents
- Lead corrective / preventive action teams
- Maintain gage calibration system
- Coordinate in process inspection, batch record review and product release
- Facilitate training of Quality Assurance team
- Maintain all Quality Assurance files and specification
- Maintain Quality Systems and certifications
- Support product launches including APQP, PPAP and IQ, OQ, PQ
- Manage customer relationships
- Supervise and lead Quality Assurance team
The candidate should have a background in medical device production (not just R&D) and have an understanding on microbiology or chemistry. This individual will also have to understand calibrations, gage R&R, visions system for measuring products and overall strong technical knowledge.
The hiring manager will be looking for someone who is a strong communicator with great work ethic and can be an influential leader.
This is an excellent opportunity for someone who is looking to take the next step in their career within the medical device space.
For immediate consideration, apply on-line now.