Sr. Quality Engineer
Company : Strivector
Country: United States
Location : Ave Maria, Florida
Post: Fri, 09 Sep 2022 03:28:57 GMT
Expires: Fri, 07 Oct 2022 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
BE THE CHOICE, NOT THE OPTION
Strivector specializes in catering to your specific desired company culture and purpose-filled job needs.
We help our clients meet their fast-growing business, new and existing positions with talented individuals like you.
Strivector works alongside Fortune 500, mid-sized and Start-ups for full-time and contract positions; on our list of companies, we have Bank of America, Fannie Mae, Philips, Smith & Nephew, Arthrex.
Take your career up a few notches with this a global medical device company leader in new product development and medical education in orthopedics.
Client is actively seeking a Sr. Quality Engineer Sutures that works directly with the Sutures Manufacturing and Engineering teams. The Sr.QE will be responsible for ensuring the overall quality of manufactured medical devices by driving and implementing improvements to manufacturing processes, test/inspection methods, defection prevention and reduction, process efficiency, and investigation/resolution of quality issues. This position requires leadership skills, the willingness and ability to mentor Quality Assurance team members and contributions beyond objectives and expected performance.
Essential Duties and Responsibilities:
Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams.
Participates in all manufacturing activities to assure compliance of design specifications.
Leads development of quality plans of new product introductions based on design specifications, PFMEA, and control plans.
Works with design team and assist/provide feedback on design specifications and improvements.
Evaluates and develops effective and efficient methods of testing and inspection of products.
Utilizes problem solving tools and techniques and apply risk based approach to problem solving.
Determines necessity of testing and initiates testing by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation.
Initiates new projects and acts as the project leader for key initiatives, identifies best practices.
Provides technical support on manufacturing technical issues.
Performs quality trending and leads/supports process improvement initiatives.
Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented.
Ensures information and documentation is consistently accurate.
Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.
Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience.
Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues and corrective and preventive actions.
May supervise other engineers, technicians, and support personnel.
Education and Experience:
Bachelor s degree in an Engineering or Engineering Technology discipline.
5 years experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques.
Manufacturing process knowledge.
Technical knowledge in development methodologies, design, project implementation, including, but not limited to GD&T, DOE, verification, and validation.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Project management skills preferred.
Recognized process improvement (i.e.: Lean, Six Sigma) and problem solving (i.e.: RCA, DMAIC, 5 Whys) training preferred.
We understand that even if you are a seasoned Sr. Quality Engineer you may not have all the skills listed here. If you are a good at what you do and have a willingness to learn, lets talk.
Compensation: Based on Experience. One of the best in the industry
Minimum Education: Bachelor of Science degree in an Engineering field required
Minimum Experience: 5 years quality control /assurance experience required
Type of position: Full time Permanent Position with benefits
Location: Ave Maria, FL
Relocation accepted: Yes
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