Position Title: Quality and Regulatory Compliance Manager
Reports to: Director of Operations
Develop, administer, and maintain the Preco Quality Management System (QMS). Provide technical and strategic leadership and subject matter expertise regarding ISO 9001, ISO 13485, ISO 14971, ISO 14644, 21 CFR 820, GMP Documentation and Regulations, and Medical Device Directive. Provide drive, leadership, and communication skills to support our mission of living a continuous improvement culture.
- Understand and perform tasks described within the QMS for Management Representative duties.
- Provide leadership in developing and executing the following processes; Internal Quality Audits, Third Party Audits, Corrective and Preventive Action, Management Review, Calibration, Document and Data Control, Risk Management, Quality Planning, Validation, and Control of Nonconforming Material.
- Provide technical leadership in determining and performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Lead and facilitate continuous improvement teams. Coach, as required, to ensure problem solving and continuous improvement tools are deployed within the organization.
- Support Preco training processes by developing and executing training programs in support of our QMS.
- Specifies and maintains QC equipment to ensure conformance to customer specifications.
- Analyze QMS metrics and develop recommendations for improvement to the Management Team.
- Oversees technical writing projects concerning the QMS.
- Evaluate product and/or process changes for impact on quality.
- Completes other tasks as assigned by supervisor.
- Four year technical degree
- Five to ten years of quality related experience with leadership preferred
- Medical device or medical device component manufacturing experience required
- Must have ISO 9001:2015, ISO 13485:2016, and FDA GMP experience
- Proven experience in project leadership regarding QMS development and deployment
- Strong background in statistics, quality inspection methods, and inspection methods
- Strong organizational, interpersonal, leadership, written communication and computer skills
- 10% travel
All Preco, Inc. employees are empowered to stop production and notify their supervisor/manager if an unsafe act or product quality concern is occurring. Also, each member of the Preco – Hudson team is responsible for identifying continuous improvement opportunities and participating in problem solving teams as necessary.
Send resume to: firstname.lastname@example.org
This position is located in Hudson, WI