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Quality Engineer


Requisition Number: P10895

Region: US
State: Wisconsin
City: Hudson

Responsibilities

  • Be a Subject Matter Expert in support of both internal and external audits.
  • Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Coordinate new process techniques that improves overall job efficiencies
  • Implement quality systems and procedures that assure compliance with Quality Standards
  • Participate in AQP/Design Development Process meetings representing quality for Phillips-Medisize, where appropriate
  • Facilitate communication between engineering functions, manufacturing, and quality both internally and externally.
  • Responsible for being a communication liaison between the customer and Design Development Center facility
  • Contribute to the design and development of components, assemblies and devices for various industries
  • Manage equipment and process validation activities for development program
  • Manage acceptance of product & deliverables
  • Participate on development teams, as appropriate
  • Must have team-centric design/product development experience and minimum of seven (7) years quality engineering experience
  • Provides direct feedback into product/process quality related decisions
  • Extended travel to other facilities may be required to support business needs
  • Some programs may have vision requirements
  • Other duties as assigned
  • Safety/Environmental:
    -Where applicable, individual is pre-planning safety into work activities to improve performance
    -Proactively identifies safety concerns
    -Complies with Environmental Management System SOP’s/WI, Policy & Program elements and encourages responsible use of resources
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
  • Completion of one of the following:
    -Submission of a continuous improvement idea
    -Active participation in a Phillips-Medisize sponsored committee or event
        (Examples include a - Rapid Improvement Event, a 5S/Lean event, Safety
        Committee, Wellness Committee, Recycling Committee, Activity Committee, or
        other Phillips-Medisize sponsored community outreach project/event (United
        Way, Junior Achievement, etc.)

Qualifications - Education & Experience

  • Four-year degree in a science (microbiology, chemistry, biochemistry) or engineering field; or equivalent mix of experience and education
  • Minimum of 8-10 years of progressively more responsible Quality experience in the medical device, combination device, and/or pharmaceutical industry. Which may include experience in managing manufacturing quality assurance with demonstrated manufacturing plant experience.

Qualifications - Skills & Competencies

  • Proven knowledge of 12 CFR 820 and ISO 13845 requirements
  • Experience in a 21 CFR 210/211 and/or 21 CFR 4 environment
  • Proficient in ISO 14971
  • Capacity to manage multiple projects and/or challenging projects with many unknowns
  • Understanding of the project development process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from all levels of an organization internally and externally
  • Strong communication (verbal and written), teamwork and organizational skills, with a proficiency in Technical Writing.
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability and experience is mentoring peers as well as junior engineers
  • Aptitude for Leadership
  • Demonstrable track record of project accomplishment
  • Demonstrable track record of planning activities with contingency actions

 

This facility operates under International Traffic in Arms Regulations (ITAR), and therefore, any person hired must demonstrate with verifiable documentation that he/she is either: (i) a U.S. Citizen; (ii) an active Green Card Holder; or (iii) a “Protected Person” as defined by 8 U.S.C. 1324(b)(a)(3).

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