Position Summary:
Ensure products are developed, manufactured, tested and delivered according to the established procedures. Provide quality engineering support in the areas of deviation management, change control, auditing, quality trends, quality costs, training, corrective and preventive actions, process control, customer complaints, calibrations, GDP and documentation control to ensure compliance with FDA, MDSAP, ISO13485 and other regulatory requirements.
Primary Responsibilities:
- 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.
- 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 chairperson and Quality reviewer/approver for change management activities.
Education, Skills, & Experience:
- Requires a Bachelor's degree in a scientific field and a minimum of 5 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques.
- Must possess effective written and verbal communication skills.
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- Must have an expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
- Certification in one of the following is highly desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
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