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Quality Manager II

Requisition Number: P11491

Region: US
State: Massachusetts
City: Clinton


  • Provide direction and leadership to the Quality department including people management as follows:  managing performance; addressing disciplinary issues; hiring; assisting people with career development; communicating information to direct reports, passing information up the management chain and fostering open communication; ensuring team is aligned with and accomplishing goals/objectives; administrative processing; and, maintaining trust and confidentiality while fostering a team environment
  • Facilitate management review activity
  • Serve as, or lead, the Management Representative, whose primary responsibility is to ensure that the facility meets internal policies and requirements, customer requirements, and facility specific quality systems
  • Supervise quality personnel, to include: scheduling, performance evaluation and planning, training/development, coaching, counseling, discipline and leading in accordance with the Phillips Plastics people process principles
  • Devise and implement quality systems/procedures that provide continuous improvement methodology supporting manufacturing and operational consistency
  • Evaluate new and changing federal, state and local regulations that impact medical device and drug operations and communicate changes throughout the organization to minimize Phillips’ exposure to regulatory risk
  • Work with Sales and Marketing, Program and Project Management to ensure that regulatory requirements are appropriately considered and accounted for in new programs and projects
  • Identify and develop resources required to support customers’ product-specific regulatory affairs needs and requirements
  • Ensure compliance with FDA/GMP and ISO quality system requirements
  • Develop quality system to support the Strategic Medical Plan
  • Interface with manufacturing, engineering, customer service and other functional areas
  • Provide technical support and coordinate quality related issues on new and existing projects
  • Oversee external customer audits
  • Develop and promote the customers’ understanding of the PPC quality philosophy
  • Coordinate internal quality system audits and track actions needed and taken
  • Work with management to establish quality goals and objectives
  • Responsible for regulatory compliance for all design controls
  • Responsible for regulatory compliance for all product labels and labeling
  • Responsible for regulatory guidance to project teams
  • Research new regulations/requirements for medical device design and manufacturing; provide analysis of the new regulations
  • Develop procedures and provide in-house training to cGMP practices and QSR’s
  • Well respected within Phillips Plastics and externally as the subject matter expert
  • Understanding of Phillips Plastics complete capabilities across multiple facilities
  • Must be an active participant in relevant councils / steering teams to promote consistency and excellence within the discipline across the Corporation

Qualifications - Education & Experience

  • B.S. degree in quality, business, engineering field or other technical field with minimum of 10 years of experience in a quality role, with at least five of those years in a lead role
  • Experience establishing systems and procedures
  • Experience in Medical discipline
  • Proven project management experience
  • Experience working with medical markets

Qualifications - Skills & Competencies

  • Good judgment; showing strong business acumen, decision quality, intellectual horsepower and perspective
  • Thorough knowledge of FDA and international regulations and standards related to medical device design and manufacturing (e.g. MDD, 21 CFR 11, 820 and ISO 13485, 14971)
  • Thorough knowledge of quality tools, such as SPC, design of experiment (DOE), root cause analysis
  • Thorough knowledge of inspection equipment and procedures
  • Thorough knowledge of ISO requirements
  • Ability to manage multiple large-scale projects
  • Ability to identify problems and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve customer satisfaction
  • Ability to facilitate effective and timely communication among quality department, internal suppliers, external suppliers and customers
  • Actively participate in the Quality Council


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