Quality Engineer

Role: Quality Engineer III

Location: Mansfield, MA

Duration: 12 Months

SUMMARY ::

The Sr. Quality Engineer II will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.The individual will utilize appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise, lead and mentor other Engineers and Technicians.

Essential Duties And Responsibilities

• EUMDR Class II & III Compliance Projects
• Works in a cross-functional team to assess Supplier Validations and general
  
  

Documentation For Compliance To EUMDR Requirements And Perform Required

remediation activities.

• Works with supplier base to identify gaps to EUMDR requirements, specifically related
  
  

to Process Validation.

• Support quality improvement initiatives such as process and product characterizations
  
  

that lead to continuous / cost improvements.

• Conduct benchmarking to develop more effective methods for improving quality.
• Approve IQ, OQ, PQ, TMV or Software Validations.
• Develop, interpret and implement appropriate process monitoring and control methods
  
  

consistent with the level of process/product risk.

• Collect data and execute/conduct various analytical/statistical analysis and
  
  

interpretation as part of process improvements and day-to-day support.

• Conduct investigation, bounding, documentation, review and approval of
  
  

nonconformances, CAPAs and customer complaints. Escalation of quality issues as

appropriate.

• Accountability and ownership for material identification, material segregation,
  
  

classification of defect types including the successful application of these techniques

on a day-to-day basis in manufacturing.

• Analyze/review effectiveness of preventive and corrective actions. Review root cause
  
  

investigation according to an established process.

It is also understood that an associate may receive special projects outside of this list

Tools And Equipment Used

• Ability to utilize a computer, telephone and copy machine as well as other office equipment.
• Strong computer skills required (Excel, Word, Power Point, Outlook, etc.).
  
  

Skill Requirements

• successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act
• (ADA), reasonable accommodations may be made to empower individuals with disabilities to
• undertake the essential duties and responsibilities of the position.
• ADVERSE WORKING CONDITIONS
• The adverse working conditions listed in this section include, but are not limited to, those
• environmental conditions to which the employee may be exposed while undertaking the essential.
  
  

Desired Minimum Qualifications

• Minimum required education and experience: Bachelor's degree or equivalent with 8
• years of experience, Master’s degree with 5 years of experience, Doctoral degree with 3 years of experience
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes is required.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.