Senior Quality Engineer

W2 only, no C2C or 3rd parties please

Candidates should have at least 4 (preferably 6 years) of new product development experience with strong knowledge of product risk management (Hazard Analysis, DFMEA, UFMEA) and design verification testing (authorship and execution of product testing). Candidates should also have experience with change control, CAPA, and ISO 13485 (direct med device experience required). There will likely be a strong preference for candidates with an understanding of software and hardware interface.

Sr Quality Engineer (12 month contract // Lafayette, CO):

Top 3 Skills:

• Risk Management (Hazard Analysis, DFMEA, UFMEA)
• Design Verification Authoring and Execution
• NPD QE skillset (Change Control, CAPA, ISO 13485 understanding)

Education Required: Bachelors of Engineering

Years’ Experience Required: 4 years of product development and verification testing experience

Description:

The Senior Quality Engineer position 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. Preferred knowledge includes mechanical and electromechanical design, design verification, design validation, process validation, risk management, and complaint analysis. As a member of the Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

Duties:

• Actively participate in product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working with Product Development to develop verification and validation testing requirements.
• Assess product risk by facilitating risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc.
• Collect, analyze, and interpret statistical data; provide reports to management.
• Contribute to Design and Process Validation initiatives by planning/reviewing validation and qualification activities (System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses, Process Capability Analyses).
• Assure proper implementation of quality engineering tools.
• Provide solutions to a wide range of difficult challenges; work independently to develop practicable solutions consistent with organizational objectives.

Embedded Responsibilities:

• Organizational and communication skills (oral/written); able to work individually and in teams.
• Problem solving and analysis skills.

Required Experience:

• B.S. in Engineering, Math, Physical Science, or equivalent with 5 years of engineering or Quality experience
• Electro-mechanical design/manufacturing process knowledge (designing, troubleshooting, improving, qualifying designs for sustainable manufacturing of medical devices)
• Experience with Minitab (or similar statistical tools)
• Experience with Risk Management Tools
• Strong interpersonal skills; effective in team environments
• Fast-paced environment adaptability; able to work under pressure with a positive attitude
• Strong attention to detail and accuracy; ability to balance/prioritize multiple projects (Project Management/Coordination skills)
• Initiative, self-motivation, strong analytical/problem-solving skills

Preferred Experience:

• M.S. in Engineering, Math, Physical Science, or equivalent with 4 years engineering/Quality experience
• Bachelor’s with 6 years in a regulated industry
• ASQ Certified Quality Engineer (CQE)
• Knowledge of medical device development/manufacturing in compliance with Quality System Regulations, ISO 13485, ISO 14971, ISO 60601
• Understanding of software and hardware interface