Job Description

Senior Engineer, Quality Assurance Engineering

Position: Senior Quality Engineer
Location: Remote (USA home office)
Duration: 6 months with possible extension
Pay Terms: Up to $70.00/hr. by W2
 
Description:

Support Quality Engineering activities in new product development to ensure the highest level of product and process quality.

Essential duties & responsibilities:

• Develop quality assurance documentation to support new product development process and regulatory submissions.
• Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
• Engage in the design, development, manufacturing, and risk management activities for new product development projects.
• Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
• Complete final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
• Promote efficient testing practices. Support Advanced Operations in the development of manufacturing processes for new products.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
• Develop, review, and approve inspection plans, routers, and product drawings for new products.
• Support product design transfers to internal and/or external manufacturing facilities.
• Evaluate predicate products for relevant quality issues that may impact new product development projects.
• Analyze and define critical quality attributes for product and process through risk analysis techniques.
• Participate in collection of initial market feedback on new products and address early concerns.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Lead investigation and health risk assessment for post-market events.

• Minimum of 2 years work experience in Medical Device or other regulated industry preferred.
• Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Demonstrated ability to read and interpret CAD drawings. Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
• Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
• Demonstrated ability to advocate for product excellence and quality.
• Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing. Strong interpersonal skills, written, oral communication and negotiations skills.
• Strong in critical thinking and "outside the box" thinking.
• Highly developed problem solving skills. Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Demonstrated ability to work independe
  To apply please email your resume to hwalsh@rothstaffing.com

Job Snapshot

• Employee Type:Full-Time
• Location:Home-Based, NJ
• Job Type:Engineering
• Experience:Not Specified
• Education:Not Specified
• Date Posted:3/24/2023
• Contact: Heather Walsh (949) 620-0292
• Pay Range: $0.00 - $70.00 Hourly

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