Senior Quality Engineer

Senior Quality Engineer

100% onsite

Position Summary:

Ensures products and services are developed, manufactured, tested and delivered according to the established procedures. Provides Quality Engineering support in the areas of nonconformance management, root cause investigations, corrective and preventive actions, process control and validation, deviation management, change control, continual improvement, internal auditing, quality trends, quality costs, training, calibrations, documentation control to ensure compliance with the FDA and other regulatory requirements. Performs all duties using safety and quality conscious practices.

Primary Duties:

1. Leads the effective closure of nonconformance reports in a timely manner by assisting Manufacturing, R&D, and other functions complete their documentation correctly and consistently.

2. Assists team members in root cause investigations to determine the most effective corrections or corrective actions.

3. 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.

4. Acts 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.

5. Leads continual improvement projects to Manufacturing and/or Quality processes.

6. Utilize statistical techniques to ensure robust and supportable actions to address issues or improve the system.

7. Provide quality support and approval signatures for Validations, Verifications, Qualifications, and Technical Reports, as required.

8. Resolve, and trend department deviations, ensuring compliance of all records to quality procedures.

9. Provide periodic trend reporting as required (QSMR, weekly and quarterly trending, monthly site metrics).

10. Act as principal Quality contact for department risk management activities.

11. Review and approves First Article Inspection of components as needed.

12. Participates in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality. Also participates in the site Internal audit and compliance review programs.

13. Provide input and approval in QC inspection methods as needed.

14. Act as Change Review Board chair person and Quality reviewer/approver for change management activities.

15. Review Bill of Material (BOMs), Assembly Procedures, Drawings, and Component Specification for accuracy.

16. 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.

17. Participates in the development and execution of training programs (GMP, risk analysis, statistics, etc.) as needed. Supports continuous improvement and Global projects as needed.

Knowledge, Experience, & Skills:

1. Requires a Bachelors degree, preferably in a scientific field.

2. Requires a minimum of 5 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques.

3. Determined to always do the right thing for the customer and business

4. Demonstrates impeccable attention to detail

5. Must posses effective written and verbal communication skills.

6. Self-motivated and trustworthy team player, embodying integrity with every interaction

7. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).

8. 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.).

9. Certification in one of the following is highly desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.

Other Conditions:

• Must be able to lift 5-10lbs
• Must be able to walk 25% of time, stand 25% of time, sit 50% of time, andtype 40% of time.
• Excellent personal hygiene required in production and laboratory areas.