Design Assurance Engineer

Contraline

Contraline is seeking a Design Assurance Engineer to actively manage Design Controls and Risk Management activities for our medical devices. The position requires flexibility and patience in a small, dynamic and innovative environment while you collaborate with some of the best talent in the male contraception industry.

This position required maintaining up to date knowledge of all applicable international and regulatory guidance, GMP standards as well as in-depth product knowledge. The successful candidate will need strong leadership, problem solving, and diplomatic abilities to excel in this role.

Key Responsibilities

  • Work with Contraline’s product development team to plan and execute compliant, risk-based approaches to procedures, plans, design requirements & specifications, technical standards, and equipment verification/validation and verification and validation activities.
  • Represent Quality and Design Assurance in engineering/R&D core team meetings.
  • Establish and maintain Design History and Risk Management Files along with related records for Contraline products in our Quality System (DHF/RMF, DMR, DHR, etc).
  • Partner with R&D to develop and provide feedback on all design documentation including user needs, inputs, product specifications, verification and validation plans and reports.
  • Provide Quality Engineer and Design Assurance support to Engineering to ensure compliance with applicable regulations and enable ongoing innovation.
  • Lead Risk management activities in conjunction with our R&D team.
  • Lead Design Reviews and manage related records, and activities to completion.
  • Oversee change management for design changes.
  • Partner with design teams on human factor study development and execution.
  • Drive and support updates to Quality System documentation outside of design controls and risk management as needed.
  • Support internal and external audits.
  • Collaborate with R&D team and external partners on component qualification, as well as equipment verification/validation.

Experience and Qualifications

Education:

  • Bachelor’s degree or equivalent experience (engineering or technical discipline degree desirable).
  • 3+ years’ experience in a quality role (quality engineer, design quality engineer).
  • Previous responsibility for design controls/risk management and related records, specification writing, statistical analysis, report writing, design transfer and medical device design reviews.
  • Demonstrated experience and responsibility for compliance for FDA, MDD and ISO regulations.
  • ASQ Certification preferred.

Experience:

  • Demonstrated proficiency in medical device Quality Management System regulations, standards and guidance including ISO 13485, FDA 21 CFR 820 and relevant documents.
  • Thorough understanding and application of EN ISO 14971, 21CFR820.30 and related subparts.
  • Familiarity with new product development best practices.
  • Strong interpersonal skills, communication (verbal and written), organizational and project management skills.
  • Ability to motivate and influence people to ensure enterprise-wide compliance to regulatory requirements.
  • Committed to a team-oriented approach.
  • Ability to work both independently and with general direction.
  • Ability to work remotely as needed.
  • Ability to travel as required.

Sector

Devices & Instrumentation

Job Type

Full-time

Benefits

  • Medical/Vision/Dental Insurance
  • 401(k)
  • Paid Maternity/Paternity Leave

Address

Charlottesville, Va.
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