Quality Engineer & Manager at Phillips-Medisize
Posted in Other 30+ days ago.
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Type: Full Time
Location: Menomonie, Wisconsin
Phillips-Medisize, LLC is seeking a Quality Engineer & Manager to help support our Phillips-Medisize Medical Facility in Menomonie, WI.
Shift: 8 Hour First Shift
Key Responsibilities of the Position
* Provide direction and leadership to the Quality department (Quality Lab and First Article Inspectors) 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
* Be a technical resource for the initiation and implementation of continuous improvements on new and existing programs
* Coordinate new process techniques that improve overall job efficiencies
* Implement systems and procedures that assure compliance with Quality Standards
* Participate in AQP meetings representing quality, where appropriate
* Provide engineering team with information and analysis tools as needed
* Facilitate communication between engineering function, manufacturing, and quality
* Responsible for being a communication liaison between the customer and manufacturing facility
* Extended travel to other facilities may be required to support business needs
* Some programs may have vision requirements
* Complies with Environmental Management System program SOP s/WI, Policy & Program elements and encourages responsible use of resources
* Other duties as assigned
Education / Experience
* Bachelor degree in an engineering discipline or equivalent experience, per engineering criteria matrix
* Minimum six (6) years quality/regulatory experience
Skills / Competencies
* Understanding of the project development process, associated terminology, and quality system requirements
* Ability to effectively present information and respond to questions from group of managers, sales, and customers
* Strong communication (verbal and written), teamwork and organizational skills
* Ability to identify problems, and develop and implement actions to resolve them
* Ability to motivate and influence people to achieve customer satisfaction
* Demonstrable track record of project accomplishment
* Demonstrable track record of planning activities with contingency actions
* Experience with: Process Failure Mode Effect analysis, Inspection Plan Lot Release documents, IQMS, MRB, Deviations, CAPA, Bill of Materials, Device Master Record, Verification/Validation, Test Method Development/Validation, Batch Records/Review, Certificates of Conformance, Statistics, Sample Plans/AQL, Prints/Drawing/Specification, GD&T, Gage R&R, First Article Inspection as examples.
* Experience with: ISO 13585, ISO 14971, CFR 820, CFR 210, CFR 211
This position does not qualify for VISA sponsorship
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) ac active Green Card Holder; pr (iii) a "Protected Person" as defined by 8 U.S.C. 1324(b)(a)(3).
About Phillips-Medisize, LLC
Phillips-Medisize, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.
Visit us: www.phillipsmedisize.com
Phillips-Medisize History: www.phillipsmedisize.com/about-us/history
Molex, LLC is an affirmative action/equal opportunity employer.
We are an equal opportunity employer. Minority/Female/Disabled/Veteran