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Form of workJob Description
Responsibilities
The Quality Lab Supervisor develops procedures, controls shift staffing, directs, trains and coordinates the supervision of Quality Assurance inspection and lab personnel. Will act as primary for enforcement of ISO 9001 and ISO 13485 standards within the testing lab environment.
- Assist in the development of departmental procedures and work instructions.
- Ensure that QA personnel are trained and follow all departmental and facility procedures and work instructions.
- Ensure that documentation is maintained and managed.
- Ensure all testing records are verified, maintained and managed to include electronic and hard copies.
- Handle and coordinate SPC and data collection process. Responsible for making decisions to accept or reject product using factual data.
- Monitor and control the staffing and scheduling of inspectors for proper shift coverage.
- Fill in for inspectors when on vacation or a scheduled day off.
- Implement continuous process improvement within the department to increase efficiencies and performance of the Quality Lab.
- Control of untested and tested retains and entire retain area. Assist in the control of inspection and test records.
- Support quarterly ISO and Safety audits for all areas of manufacturing and office.
- Oversee the NCR/Quarantine area, coordinate NCR handling and disposition, and prepare reports of monthly costs of NCRs.
- Prepare employee performance reviews and conducts one-on-one counseling with employees when warranted.
- Manage the testing information insure accuracy and currency of information.
- Oversight of the specification revision process through QA support staff. Review and approve initial and revised specifications to ensure quality product.
- Coordinate the activities for (or create) Certificates of Analyses to meet customer requirements.
- Supervise the process for production file close outs performed by QA support staff to ensure records are complete and demonstrate compliance to requirements.
Must Haves
- HS Diploma or equivalent required
- 2+ years of QA Lab Supervisor experience in an ISO 13485 environment required
- Flexible packaging industry experience is preferred
- Proficient in MS Office (Excel, Word and PowerPoint and Outlook) required
- Previous ERP experience is a plus
- SPC software experience is required
- Strong Knowledgeable of regulatory requirements in an ISO 13485 environment is required
- Strong organizational skills and ability to effectively communicate and share knowledge with others required
Works well with other departments in communication of timelines, priorities and resolving ambiguous tasks/situations
