As a Quality Manager, you will provide leadership to our Quality Control team and oversee all incoming and in-process quality inspections. You will oversee the maintenance of quality records following existing Standard Operating Procedures, and will drive continuous improvement and efficiency while also maintaining our quality standards.
How You'll Contribute
- Manage incoming, in-process, packaging, labeling, and engineering development inspections.
- Ensure that FDA Quality System Regulations (QSR), Medical Device Directive (MDD), and applicable ISO requirements are in place and being followed for inspection-related activities.
- Use your expert knowledge of our Quality System to formulate and carry out company directives.
- Utilize your leadership skills to supervise, coach, evaluate, and motivate a team of Quality Supervisors, Inspectors and Specialists.
- Allocate team members and material resources as needed.
- Use your strong interpersonal skills to Interface with the FDA, State agencies, and notified bodies during routine ISO audits and FDA inspections.
- Ensure that health and safety guidelines are followed.
What You Bring
- Solid analytical and decision-making ability and leadership skills.
- Experience in statistical and data analysis.
- A thorough knowledge and understanding of FDA QSRs, ISO standards, and the MDD.
- Knowledge of sterilization requirements for medical devices.
- Proficiency with technical writing of protocols, analytical reports, ECOs, SOPs, Work Instructions, and Inspection Methods.
- Practical knowledge in Statistical Process Control, Process Capability, Gage R&R, DOE, software Quality Assurance, electronic records, and risk analysis.
- Bachelor of Science degree and a minimum of 8 years equivalent combination of education and experience in the quality assurance or engineering in the life sciences industry.
- ASQ certifications for CQE, CQA, CQM, or equivalent preferred.