Sr QA Engineer

Medtronic. Careers with a passion for life.
As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.

Sr QA Engineer
Santa Ana, California

Assure that all Quality requirements are in compliance with FDA, GMP, ISO 13485, MDD, CMDR, CMDCAS and other national and international standards.
Provide Quality Assurance technical leadership and support to operational areas (Manufacturing and Product Development) in order to ensure product quality and safety.

Responsibilities: • Assure all Quality requirements are in compliance with standards and specifications.

• Provide quality and technical leadership and support to all manufacturing areas.

• Resolve non-conformances (e.g. NCR’s) by using problem solving techniques Six Sigma tools, and implement corrective action including investigation of customer complaints. This may include functional testing of heart valves.

• Review and approve changes to tissue valves in manufacturing process for quality and reliability impact to aid in the correction of process, design, or material problems.

• Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA. Related to tissue heart valves products.

• Develop and maintain systems to assure GMP compliance to communicate any lab output to internal / external customers.

• Write protocols as needed (e.g. test procedures and qualification and validation plans and reports).

• Perform statistical analysis including determination of sample size, design of experiment, hypotheses testing, and a Six Sigma tools as applicable.

• Support manufacturing and product development projects.

• Performs other duties as assigned.
REQUIREMENTS
Requirements: • BS degree in Engineering or related field.

• ASQC Certified Quality Engineer or Reliability Engineer.

• Knowledge of GMP, ISO 13485 and MDD, CMDR, CMDCAS.

• Training in Customer Focused Quality and / or Process Improvement.

• Minimum of five (5) years experience in the medical device field.

• Project Management.

• Good written and verbal communication skills.

• Quality Engineering Statistical Tools.


We are currently seeking multiple individuals for Engineering opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Santa Ana, California. Other opportunities may also exist at our locations in Minneapolis, Minnesota; Northridge, California; Santa Rosa, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.

With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.

TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Engineering openings or enter Requisition # 52687 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.

Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.