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Description
At Boston Scientific, we believe that collaboration is the key to developing innovative ideas. It's that kind of teamwork that leads to tomorrow's medical breakthroughs. Our Maple Grove Cardiovascular Division has the following Senior Quality Engineer position available:
The job responsibilities include:
· Provide technical expertise in the areas of compliance, new products & projects for the Operations Quality Stent Value Stream.
· Drive substantial compliance through leadership and training initiatives.
· Aid in the initiation of guidance documents to drive substantial compliance.
· Team lead for projects including improvement, problem solving & investigation activities.
· Utilize statistical analysis and problem solving methodologies to determine product acceptance, evaluate process capability and resolve quality issues.
· Review and approve product, process, software qualification and validation and other change control related documentation.
· Provide strong mentorship to department engineering staff, particularly in the areas of pharmaceutical requirements, cleaning validation, and laboratory/analytical methods
Required Qualifications:
· Bachelors degree --Engineering, Science or technical degree preferred
· Minimum of 7 years related experience within the medical device or pharmaceutical industry
· Demonstrated application of Quality tools, including Six Sigma, Lean and statistics
· Demonstrated strong interpersonal and leadership skills with strong teamwork ethics.
· Strong written and verbal communication skills
· Demonstrated leadership in the application of pharmaceutical regulations
· Experience with developing and implementing cleaning validations
· Knowledgeable of common laboratory methods and analytical techniques
Apply Here
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