Position Summary & Responsibilities:
Ensure products and services are developed, manufactured, tested and delivered according to the established procedures. Provide quality engineering support in the areas of deviation management, change control, internal auditing, quality trends, quality costs, training, corrective and preventive actions, process control, customer complaints, calibrations, documentation control to ensure compliance with the FDA and other regulatory requirements.
- Participate in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality. Participate in the site Internal audit and compliance review programs.
- Resolve and trend department deviations, ensuring compliance of all records to quality procedures.
- Provide periodic trend reporting as required (QSMR, weekly and quarterly trending, monthly site metrics).
- Act as principal Quality contact for department risk management activities.
- Participate and provide guidance for Supplier change checklist process, as required.
- Act as a quality contact for evaluation of incoming QC and in-process materials. Ensure the disposition of non-conforming materials meet all site and regulatory requirements.
- Provide quality support and approval signatures for Validations, Verifications, Qualifications, and Technical Reports, as required.
- Review and approves First Article Inspection of components as needed.
- Participate in site CAPA activities, including analysis of data and trends, nonconforming material, complaints, training effectiveness, and root cause analysis. Coordinates the implementation of corrective actions and preventive measures as needed.
- Provide input and approval in QC inspection methods as needed.
- Act as Change Review Board chair person and Quality reviewer/approver for change management activities.
- Review Bill of Material (BOMs), Assembly Procedures, Drawings, and Component Specification for accuracy.
- Monitor the manufacturing of assigned products, ensuring compliance with DMR while providing deviation/waiver guidance. Ensures complete and correct Device History Records are maintained through DHR review and periodic audits.
- Participate in the development and execution of training programs (GMP, risk analysis, statistics, etc.) as needed. Supports continuous improvement and Global projects as needed.
Education, Skills, & Experience:
- Bachelors degree in a scientific field and 3+ years related experience with competence in the selection and use of Quality Engineering Tools and Techniques.
- Certification in one of the following is highly desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
- Must posses effective written and verbal communication skills.
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
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