Job Title:

Quality Manager

Requisition Number:

1780

Location:

Design Development - Hudson, Wisconsin

Responsibilities:

• Thorough knowledge of current good manufacturing practice (cGMP)
• 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)
• 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
• Coordination and facilitation of the management review process
• Serving as the Management Representative, with primary responsibility for ensuring that the facility meets internal policies and requirements, customer requirements, and facility-specific quality systems
• Supervision of Quality personnel (e.g. quality engineers, inspectors, coaches and/or technicians), to include scheduling, performance evaluation and planning, training/development, coaching, counseling, discipline and leading in accordance with the Phillips Plastics people process principles
• Integration of the quality and compliance function with manufacturing, engineering, customer service and other functional areas
• Providing technical support and coordination on quality-related issues for existing product operations and new product introduction
• Facilitating and continuously improving communication between Quality and other functional departments
• Providing leadership in communication and interaction with customers in order to ensure that customer expectations are continually met or exceeded
• Development and promotion of the customers' understanding of the Phillips quality philosophy and its value proposition
• Managing the timely evaluation, investigation and resolution of customer complaints related to product quality 

  Managing the CAPA program to ensure that corrective and preventive actions are implemented in a timely and effective fashion, and are tracked and documented appropriately

  • Coordination of customer and internal quality system audits, including tracking and resolution of resulting corrective actions
  • Leading and/or participating in quality system audits at other Phillips facilities
  •Representing DDC facility on the corporate Quality Council, and actively participate in its activities

Qualifications:

• A B.S. degree in a manufacturing, quality, engineering, or related technical field, or equivalent combination of education and work experience
• A minimum 5 years' experience in a technology-driven and innovative manufacturing environment, with 3 years of supervisory or people management experience
• Demonstrated experience establishing and managing quality systems
• Experience in Lean/Six Sigma concepts

Skills / Competencies

• Working knowledge of US and international quality systems standards such as ISO 9001, ISO/TS 16949, ISO 13485 and ISO 14971, and regulatory requirements such as 21 CFR 820 and the EU's Medical Device Directive (MDD)
• Working knowledge of quality management tools such as SPC, design of experiment (DOE), and root cause analysis
• Working knowledge of inspection equipment and procedures
• Ability to read blueprints and have an understanding of geometric tolerances
• Ability to travel between facilities and to customer locations
• Strong written, verbal and interpersonal communication skills
• Ability to work with all levels within the organization as well as customers and vendors
• PC skills to include word processing, spreadsheets and database programs
• Demonstrated team leading, problem solving and project management skills
• Ability to work independently as well as part of a team

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