Senior Staff Quality Engineer
Location near North Andover, MA
Medical Equipment / Devices/ Manufacturing – Quality
Full-time Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Visa Candidate Considered: No
The Senior Staff Quality Engineer is accountable for supporting new product development and product maintenance through the application of quality engineering skills for highly complex medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. This position develops highly advanced, new applications resulting in new products. Decisions or recommendations would normally result in the achievement of goals critical to the major objectives of the company and would greatly enhance the image of the company’s quality technological capabilities. Decisions and recommendations are of the scope that if errors are made there would be an equally negative impact on achievement of objectives and company image.
• Develops quality strategy for large-scale, highly challenging programs with outstanding initiative and innovation.
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context.
• Provides critical direction and oversight to external designers, developers and manufacturers.
• Leads cross functional teams through design control activities throughout the structured development process.
• Develops advanced quality methods and guides their application into development of a final product, process or business opportunity.
• Primary core team member/extended team member for complex design control / process control projects.
• Serves as a change agent and advocate of quality culture
• Serves as Subject Matter Expert in the areas of design control and risk management and oversees completion and is accountable for Design Control requirements.
• Ensures appropriate completion of all test method validations, software validations, and supplier qualification
• Develops and initiates Post Market Surveillance plan.
REQUIREMENTS/ SKILLS AND QUALIFICATIONS
• B.S. degree, in a scientific, technical or engineering discipline.
• Master in business or scientific discipline.
• 10+ year’s progressive experience in Quality within an FDA-regulated industry.
• Extensive knowledge of applicable regulatory requirements.
• Expert in Design Controls Class II/III, Medical Device experience.
• Strong understanding and application of six sigma methodology.
• Ability to conduct internal / external Quality Systems audit.
• Training in design of experiments and statistics.
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971.
• ASQ Certified Quality Engineer, Six Sigma Black Belt or equivalent experience.
• Knowledge and experience in manufacturing, project management and engineering.
• Must possess excellent oral and written communication skills, and proven supervisory/leadership capability.
• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter.
• Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
• Ability to lead and mentor quality engineers as well as other cross-functional core team members.
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.
Title 21 Of The Code Of Federal Regulations
Certified Quality Engineer