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Quality Engineer

Collabera Saint Paul, MN
  • Posted: 15 days ago
  • Full-Time

A development quality engineer assures new or modified products conform to requirements and establishes compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Execute on-time completion of design control deliverables · Design verification and validation test planning · Writing design verification and validation test protocols, execution and reports · Design input output trace matrix · Design History File organization · Customer, system, and product requirement review · Regulatory responses and submissions · Risk/hazard analysis and risk management plan/reports · Design specification reviews · Quality plans · Design change plan/reports · Investigate internal and external audit findings and write responses · Corrective and preventive action resolution · Complete document change requests

Solid communication and interpersonal skills · Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization · Advanced computer skills, including very strong report writing skills and document control database navigation and use ·

Ability to work within a team and as an individual contributor in a fast-paced, changing environment · Self-directed: Multitasks, prioritizes and meets deadlines in timely manner with minimal oversight · Strong organizational and follow-up skills, as well as attention to detail

Medical device/ Pharma Quality engineering experience and demonstrated use of Quality tools/methodologies. Quality,CAPA,Design,Medical Device,Pharma,FDA

Collabera

Why Work Here?

Collabera has been recognized by Staffing Industry Analysts (SIA) as one of the “Best Staffing Firms to Work For” for 8 consecutive years.

Not only is Collabera committed to meeting and exceeding our customer’s needs, but we also are committed to our employees’ satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. We offer an enriching experience that promotes career growth and lifelong learning for our employees. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as one of the “Best Staffing Firms to Work For” since 2012 – eight consecutive years in a row. Collabera has 60 offices with a presence in 11 countries and provides staff augmentation, managed services and direct placement services to Fortune 500 corporations across the globe.

Address

Saint Paul, MN
55117 USA

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