Senior Quality Engineer

The Senior Quality Engineer position on the team supports new product development for Surgical Instruments. In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of mechanical and electromechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:

• Actively participate in product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
• Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc.
• Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
• Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses.
• Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

REQUIRED SKILLS AND QUALIFICATIONS:

• Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.

BASIC QUALIFICATIONS:

• B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality
• Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality
• Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline)

SPECIALIZED SKILLS OR EXPERIENCE:

• Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external.
• Experience in a regulated industry
• Experience with Minitab or similar statistical analysis tools
• Experience with Risk Management Tools
• Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships.
• Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude
• Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects.tasks (Project Management skills).
• High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.

NICE TO HAVE:

• ASQ Certified Quality Engineering (CQE)
• Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
• Understanding of software and hardware interface