Quality Engineer

Job Summary:

The Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the company's quality system while providing support to product development, operations/manufacturing, and manufacturing engineering.

Duties and Responsibilities:

• Assist in the development and maintenance of the company quality system to support medical device products and operations and ensure continual improvement in quality. This may include drafting and reviewing quality system documents, managing document change requests, and regularly reviewing procedures for accuracy and appropriateness.
• Participate in assigned project teams by providing guidance on Restor3D processes and procedures.
• Initiate, review, and conduct root cause investigations for nonconformances related to processes and/or the quality system. Identify actions needed to correct issues or prevent recurrence, verify and validate actions as appropriate to ensure effectiveness, implement and document necessary process changes, and communicate relevant findings to responsible personnel.
• Support quality control inspection by designing fixtures, authoring and updating work instructions, and implementing continuous improvement projects.
• Collect and analyze data to identify trends in manufacturing and support the quality system.
• Support the development and execution of IQs, OQs, and PQs.
• Assist with product failure and root cause investigations.
• Ensure adherence to company quality procedures.
• Support the CAPA process by managing assigned CAPAs and supporting other CAPA teams as needed. Ensure CAPAs are appropriately initiated, corrective actions are implemented, effectiveness checks are performed, and CAPAs are closed within established timelines.
• Assess CAPA data for systemic issues and develop and implement process improvements as necessary.
• Support the document management program, including policies, standard operating procedures, and forms, by developing document content, managing change and approval requirements, communicating critical changes, and providing final approval of documents as assigned.
• Review and approve production lot history records.
• Assist with and document regular management reviews.
• Participate in regulatory inspections, including those conducted by the FDA, and ensure that inspection observations are appropriately addressed.
• Advise on Design Control projects as needed.
• Review and approve custom product documentation to ensure compliance with applicable FDA requirements.
• Support continuous improvement projects for the Design Controls system.

Qualifications and Experience:

• Bachelor's degree (B.S.) in Engineering from a four-year college or university preferred, with a preference for Mechanical, Biomedical, or Materials Science Engineering.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Lean Six Sigma, or a related quality or regulatory certification is a plus.
• 1–4 years of experience in the medical device industry, with comprehensive knowledge of applicable medical device regulations, including FDA 21 CFR Part 820 and other applicable international standards.
• Hands-on experience working within a regulated quality management system, including experience with device design, testing, and FDA clearance.

Required Skills:

• Strong influencing and project management skills, with the ability to work effectively both independently and as part of a team.
• Excellent organizational, interpersonal, verbal, and written communication skills, with the ability to interface with executive management, internal cross-functional teams, and external consultants and vendors.
• Ability to exercise sound judgment, analyze problems, and develop effective solutions.
• Ability to prioritize, plan, and evaluate deliverables to meet established goals.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• SolidWorks experience is a plus.
• Ability to work in a fast paced environment.

Physical Requirements:

• Ability to travel as needed, up to 10% of the time.
• Position may involve the use of basic hand tools, inspection equipment, and cleaning equipment.
• Position may involve handling or exposure to metallic powders, mill coolant, tapping fluids, and polymeric resins.
• Limited physical requirements beyond those generally needed to participate in laboratory experiments, production activities, and similar tasks.
• Work environments may include an office, laboratory, manufacturing area, aseptic surgical settings when visiting surgical centers or observing surgeries, and travel.