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).
With over five decades of experience, Phillips-Medisize is a global-leader of outsource design, development and manufacturing services, delivering innovative and complete end-to-end capabilities to our customers. Our foundation is built on the core principles – quality, innovation and investment – which have led us to our current industry leadership position.Phillips-Medisize's mission is to ensur...e you, our customer, receive the highest level of satisfaction using our state-of-the-art technology, innovative design, creative people and appropriate facilities. Our facilities, totaling over 2 million square feet, adhere to the most rigorous global requirements while providing a quality system adaptable to local standards. The heart and soul of Phillips-Medisize is our people. Their expertise and knowledge allow us to rise to your challenge. As we partner with you through every step of the process, we are able to carefully design and build a product to meet your needs, often resulting in shortened time-to-market and reduced overall program cost.