Position Title: Project Manager
Work Location: Marlborough, MA
Assignment Duration: 1 Year

Position Summary: Provide Product Quality Engineering support on risk management and product complaint trending. This role will be responsible for reviewing each complaint record individually and identifying the appropriate risk lines and associated severities from the product's Risk Management File (RMF) that relate to what was reported by the complainant and the results of the investigation.

Key Responsibilities:

• Analyze complaint information and identify hazardous situations and harms reported through complaint information
• Evaluating content in existing Risk Management Files ensuring all hazardous situations and harms reported through complaint information is adequately captured.
• Perform trend analysis using Statistical Process Controls per applicable quality procedures.

Qualification & Experience:

• BS in biomedical engineering, mechanical engineering, or health care related discipline
• Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred
• Experienced with Quality System Regulations, ISO 13485 and 21 CFR 820.
• Experienced with ISO 14971, Risk Management
• Basic knowledge of risk analysis techniques such as FMEAs
• Basic knowledge of medical terminology and anatomy
• Basic knowledge of engineering and process terminology
• Understanding of statistics including statistical process control (SPC) - Minitab experience preferred
• Detail-oriented and committed to maintaining accuracy and compliance in all tasks
• Accountable and reliable, with a focus on timely communication and issue escalation
• Collaborative team player, open to receiving feedback and contributing to shared goal
• Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• Ability to appropriately assess written product and project documentation, and ability to effectively communicate assessment
• Experience authoring and executing risk assessments
• Working knowledge of ISO14971, 21 CFR 803 and 21 CFR 820

 
 
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: $ 45.00/hr.