Development Quality Assurance Specialist

4 days ago

Littleton, Colorado, United States 3D Systems Full time
Job Title:

Development Quality Assurance Specialist

Company Overview:

3D Systems Healthcare Solutions is a leading player in the medical device industry, dedicated to improving healthcare through innovation and cutting-edge technology.

We are seeking a qualified Intermediate Quality Engineer to join our New Product Development (NPD) team to ensure the quality and safety of our products.

Key Responsibilities:
  1. Collaborate closely with cross-functional product development teams to establish, implement, and maintain quality standards throughout the product development life cycle.
  2. Develop, execute, and oversee risk management activities, including risk assessments, hazard analyses, and risk mitigation strategies, in compliance with industry regulations and standards.
  3. Provide input and review and approve product and process validation activities.
  4. Lead and participate in design and process failure mode and effects analysis (DFMEA and PFMEA).
  5. Identify and develop test methods, inspection plans, and quality control procedures.
  6. Ensure compliance with applicable regulatory requirements, such as FDA, ISO, ITAR, and other relevant standards.
  7. Investigate and address product non-conformances, root cause analysis, and implement corrective and preventive actions (CAPA) where appropriate.
  8. Provide guidance and support to the design and engineering teams to address quality concerns and improve product design and manufacturability.
  9. Assist in supplier quality management and supplier audits to ensure the quality of incoming materials and components.
  10. Maintain accurate quality documentation, including design history files, risk management files, and test records.
  11. Collaborate with regulatory affairs and provide input for regulatory submissions.
  12. Continuously monitor industry trends and regulatory updates to stay current with best practices and compliance.
Requirements:
  1. Bachelor's degree in engineering, preferably in biomedical, mechanical, or a related field; or equivalent combination of education and experience.
  2. 3-5 years of experience in quality engineering, preferably in the medical device industry.
  3. Knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO).
  4. Strong understanding of quality tools and methodologies, including FMEA, CAPA, and statistical analysis.
  5. Quality certifications (e.g., ASQ Certified Quality Engineer) desirable.
  6. Experience with product and process validation, design control, and risk management.
  7. Excellent problem-solving and analytical skills.
  8. Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
  9. Detail-oriented with a high level of accuracy in documentation.
  10. Ability to work independently and prioritize tasks in a fast-paced environment.
  11. 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.

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