Associate Staff Quality Engineer

bioMerieux - Durham, NC

Posted 738 days ago
  • Experience
  • Job function
    Quality Assurance
  • Employment type
  • Industry
    Medical Devices
  • Employer job ID
  • Job ID

This is a preview of the Associate Staff Quality Engineer job at bioMerieux. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

In this position, you will be responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations.  You will provide expert guidance to all levels on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.  You will also ensure products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements.

1. Document quality systems and programs in the areas of management responsibility, auditing, quality trends, quality costs, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, customer complaints, calibration, documentation control, etc. to ensure compliance with FDA, and regulatory requirements.

2. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

3. Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.

4. Responsible for reviewing the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, etc.

5. Specify and develop special inspection equipment, fixtures, and procedures in conjunction with manufacturing.

6. Responsible for ensuring that the disposition non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent reoccurrence.

7. Quality Engineering Support for Design Control Process -Develop and implement project Quality Plan (as necessary), review and approve to Design Specifications, Design verification and validation protocols, facilitate and participate in design reviews, develop quality-engineering deliverables and assure Design History File (DHF) is updated (as necessary).

8. Execute Internal/Supplier Audits.

9. Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.  Coordinate implementation of corrective actions and preventive measures.

10. Develop and establish statistical sampling plans for validation, incoming inspection, etc.

11. Develop and execute training programs (e.g. change control, GMP, risk analysis, statistics, etc.).

Desired Skills and Experience

. Bachelors Degree with 7 - 9 years industry experience or equivalent experience in related industry
2. Masters Degree preferred.
3. Ability to work independently and in team environment.
4. Ability to effectively communicate verbally and in writing.
5. Competence in the selection and use of Quality Engineering Tools and Techniques. 
6. Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
7. Certified Quality Engineering (CQE), Certified Quality Auditor (CQA) or Six Sigma Black Belt desired. Masters Degree in a scientific or technical field desired.

bioMerieux, Inc. is an Equal Opportunity/Affirmative Action Employer m/f/d/v

About this company


Scientific and technological innovation is at the heart of bioMérieux's strategy. A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux designs, develops, produces, and markets diagnostic systems for medical and industrial applications. bioMérieux's solutions (reagents, instruments, and software) are used to determine the source of disease and contamination to improve patient health and ensure consumer safety. To fulfill its mission to improve public health worldwide, bioMérieux is present in more than 150 countries through 39 subsidiaries. Its world headquarters are located in the Lyon area in France. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

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