Position Title:Engineer, Quality
Work Location: Westford MA
Assignment Duration: 12 months (possibility of extension)
Work Arrangement: Onsite

• The purpose of this position is to initiate medical device quality assurance activities. 
• These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. 
• This position will also support device complaint investigation and failure analysis as required. 
• Essential Duties and Responsibilities: 
• Develop incoming inspection processes and document incoming inspection activities. 
• Provide in-process QA support to include inspection and document review. 
• Complete final acceptance activities. 
• Manage the sterilization process, including validations and product sterile loads. 
• Track nonconforming material and lead Material Review Board (MRB) efforts. 
• Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. 
• Lead complaint investigations on returned product. 
• Manage corrective action and quality improvement activities. 
• Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. 
• Establish, monitor and evaluate quality system metrics.

Additional Details 

• 2-3 years minimum of Quality Engineering experience, preferrable in Medical Device Manufacturing. 
• I will accept experience in Pharma or Electronics.
• Relevant experience must be in a highly regulated industry. 
• They should have experience with working on and executing tasks for projects, risk review, CAPA, and problem solving. 
• Please don’t submit candidates with 15 years’ experience or have recently held Manager or above jobs, as they will be considered overqualified.
• Skills: Risk assessment review, Correct/Preventative Actions, inspection plan creation, documentation change management, problem solving/DMAIC, project management, time management 
• General Description of Work: 
• This candidate will be working on several high quality impacting projects at the Westford Manufacturing facility. 
• They will be a part of our post-market “Sustaining Quality Engineering” team and be supporting projects related to post-market updates to our products. 
• This includes maintenance of risk documentation, MPIs, design change evaluations, and support of complaint investigations and analysis. 
• This person will be expected to be prompt, organized, independent, and an aggressive problem solver. 
• We need a candidate with a proven track record of coming up to speed quickly, strong work ethic, and a dedication to supporting life-saving medical devices

  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/daily.