Quality Engineer II

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

As a Quality Engineer, you'll play a critical role in ensuring our product integrity and driving continuous improvement in a fast-paced, production environment. This position offers the opportunity to apply your technical expertise to campus-wide digitization initiatives as we transition our business to Industry 4.0/5.0. Prospective candidates must have strong understanding of cGMP, strong communication skills, and keen attention to detail.

What will you be doing?

• The Quality Engineer will report to the Operations Quality Engineering Team. This role works cross-functionally with other departments to support daily production targets, transformational projects, and continuous improvement initiatives. This role is responsible for maintaining compliance to internal and external standards and regulations, both within the QMS and on the production floor.

• Coordinates and leads countermeasure meetings to review processes, perform gap analyses, and implement new technologies.

• Works with cross-functional teams in the resolution of quality problems, which may involve processing of NCRs, CAPAs, material dispositions, data trending and analysis, and presentation to internal customers and external vendors.

• Develops, documents, and implements various inspection techniques and procedures to ensure product integrity to design specifications.

• Coordinates with other Engineers and Metrology personnel on the review, design, development, and procurement of product gauging.

• Coordinates development and implementation of digitized processes, which may include writing work instructions, app development, and case testing.

• Trains Manufacturing and Quality Control associates on business processes and inspection techniques.

• Works with Manufacturing Engineers to perform first article inspections, capability studies, validations (IQ, OQ, PQ), and engineering analyses to characterize products, processes, and materials.

• Coordinates with Design Quality and Product Development on new product introductions, including the evaluation of critical features and proposed inspection techniques.

What will you need to be successful?

• Education: Bachelor of Science in Mechanical, Manufacturing, Electrical, Biomedical, Industrial Engineering, or equivalent technical discipline required.

• Licenses/Certifications: ASQ CQE and Six Sigma Green / Black Belt preferred.

• Experience: 2 or more years in an Engineering or equivalent technical role. Experience in quality or engineering in a regulated manufacturing environment highly preferred.

• Ability to read, analyze, and interpret technical documents and GD&T, academic publications, operational procedures, and government regulations.

• Ability to effectively write technical reports, business correspondence, and operational procedures.

• Ability to effectively present information, both orally and written, to a range of cross-functional audiences, including operators, customers, and management.

• Ability to apply advanced mathematical concepts for data analysis and problem solving, such as probability and statistical inference, trigonometry, and algebra.

• Ability to clearly define problems, collect data, establish facts, and draw valid conclusions through root cause or gap analyses.

• Prior experience in statistical analysis and/or software development preferred.

• Prior experience with Tulip, Jira, and Agile methodology strongly preferred.

• Physical: Ability to measure product using simple hand instruments, stand, or sit for extended periods.

• Physical: Vision must be excellent or corrected.

• Travel: 0-10%

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