Job: Quality Engineer Med Device (Baltimore, MD)
Job ID: 01710217
Location: Baltimore, MD
Salary: $80000 – $110000
Date Listed: Jan 20, 2010
Job Type: Full Time
Suggested Degree Level: Bachelor
General Comments:
Our client is a global manufacturer of disposable medical devices who is looking for a Senior QUALITY Engineer to provide expert guidance on product design and processes as they relate to compliance with QUALITY system requirements.
1. Provide QUALITY engineering support for product development group.
2. Qualify suppliers and monitor their performance.
3. Track QUALITY trends and initiate action items to resolve issues. Manage assigned corrective actions and complaint investigations.
4. Proactively investigate, identify and implement best in class QUALITY engineering practices
5. Provide training and support for QUALITY system processes and QUALITY engineering practices.
6. Identify and support effective process controls to support the qualification and on-going manufacturing of products.
7. Write, facilitate, execute and review complex validations independently and efficiently (including validations over many product codes, multiple assembly lines, to appropriate degree of confidence in keeping with company procedures).
8. Participate in internal and external QUALITY audits.
9. Suggest and lead system-wide QUALITY based initiatives involving multiple departments.
10. Assess and recommend QUALITY requirements for new products and acquisitions.
Position Requirements
1. Must have a 4 year technical degree preferably in engineering.
2. Ten years of related experience in medical device product development in a QUALITY engineering role. Must have experience working directly with production (on the floor) and understanding of manufacturing processes.
3. Typically requires minimum of 1 year of auditor experience, extensive experience with complaint problem solving and continuous improvement projects.
4. Must have design control experience and experience working with design control charts.
4. Typically is certified as a CQA or CQE and member of the ASQ
http://employment.topechelon.com
