Medical Device Quality Engineer - Colorado, United States - HireMinds

Description

Quality Engineer II

HireMinds has partnered with a leading player in the medical device industry, dedicated to improving healthcare through innovation and cutting-edge technology. We are seeking a qualified Quality Engineer to join the New Product Development (NPD) team to ensure the quality and safety of their products.

As an Intermediate Product Development Quality Engineer, you will play a pivotal role in the design, development, and quality assurance processes of cutting-edge medical devices. You will work closely with cross-functional teams to ensure compliance with industry regulations, meet customer expectations, and deliver high-quality products to the market.

Responsibilities:

• Collaborate closely with cross-functional product development teams to establish, implement, and maintain quality standards throughout the product development life cycle.
• Develop, execute, and oversee risk management activities, including risk assessments, hazard analyses, and risk mitigation strategies, in compliance with industry regulations and standards.
• Provide input and review and approve product and process validation activities.
• Lead and participate in design and process failure mode and effects analysis (DFMEA and PFMEA).
• Identify and develop test methods, inspection plans, and quality control procedures.
• Ensure compliance with applicable regulatory requirements, such as FDA, ISO, ITAR, and other relevant standards.
• Investigate and address product non-conformances, root cause analysis, and implement corrective and preventive actions (CAPA) where appropriate.
• Provide guidance and support to the design and engineering teams to address quality concerns and improve product design and manufacturability.
• Assist in supplier quality management and supplier audits to ensure the quality of incoming materials and components.
• Maintain accurate quality documentation, including design history files, risk management files, and test records.
• Collaborate with regulatory affairs and provide input for regulatory submissions.
• Continuously monitor industry trends and regulatory updates to stay current with best practices and compliance.

Qualifications

• Bachelor's degree in engineering, preferably in biomedical, mechanical, or a related field; or equivalent combination of education and experience.
• 3-5 years of experience in quality engineering, preferably in the medical device industry.
• Knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO
• As this role includes development of parts covered under ITAR, candidate must be a US Person.
• Strong understanding of quality tools and methodologies, including FMEA, CAPA, and statistical analysis.
• Quality certifications (e.g., ASQ Certified Quality Engineer) desirable.
• Experience with product and process validation, design control, and risk management.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Detail-oriented with a high level of accuracy in documentation.
• Ability to work independently and prioritize tasks in a fast-paced environment.
• Applied experience with and understanding of additive manufacturing a plus.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• A collaborative and innovative work environment.
• Access to cutting-edge technology and resources.
• Contribution to the development of life-saving medical devices.

Salary Range: $75,000 - $100,000 (Salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data)

In addition to a salary, this position is eligible for an annual bonus based upon company performance. Company offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and 8 holidays per year are also provided as paid time off. Company also provides a 401(k) Retirement Savings Plan option with a company match.