Menomonie, WI, United States
Engineering, Quality, Manufacturing
Quality Systems Engineer
↵1st Shift: 5:00AM - 1:30PM Monday through Friday
Phillips-Medisize, LLC is seeking a Manufacturing Associate to support all activities related to manufacturing.
Responsible for performing varied and general tasks involved in manufacturing process. These tasks include, but are not limited to; basic manufacture, assembly, labeling cables, packaging, in-process testing, operation of basic hand tools and operation of assigned production/manufacturing.
Must be able to work in a bench-top assembly environment using a variety of manufacturing equipment while prepping, stripping, tinning, crimping and soldering of medical cables.
Must be able to work in a lean 5S environment.
Accurately record process documentation.
Must be able to interpret, read and follow all work instructions and engineering drawings.
Must comply with all safety requirements including; manufacturing practices and procedures, standard operating procedures and manufacturing documentation.
Job Title:Quality Systems EngineerJob Description:Position Overview: Phillips-Medisize, a Molex Company, is seeking a Quality Systems Engineer to serve as global resource and subject matter expert to manage Corporate Quality Management System and regulatory requirements for cGMP, ISO13485. Essential Functions: Support product compliance by working with the Quality organization.Evaluate processes for updating techniques, quality and overall efficiency to improve operationsInstill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activitiesRegularly research and evaluate regulatory trends to insure the compliant systemsHelp employees improve upon or enhance existing skillsIdentify training and compliance gaps and address with appropriate departmentsProvide periodic status updates and reportsReviews regulatory, program and customer requirements ensuring early quality involvement in program developmentOther duties as assigned Job Number:7358BRCareer Field:Quality Assurance / Safety Position Qualifications:Required Qualifications: BS plus two years of related experience within a regulated environment, or equivalent industry experience Knowledge of GMPs Regulations (13485, 820, 210/211, EU)Internal Auditor (external lead training preferred) Skills and Abilities:Strong communication, teamwork, and organizational skillsAbility to manage small projects/programs with limited assistance from othersKnowledge of FDA Quality System Requirements, ISO 13485, ISO 9001, ISO 14971 and other medical device regulations, both domestic and international.Ability to work effectively with all levels of management, co-workers, and external regulatorsAbility to read and interpret FDA Guidelines, professional journals and technical proceduresStrong decision making and prioritization skillsStrong analytical ability and proficient in data collection and presentation 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. Learn more...Visit us: www.phillipsmedisize.comTwitter: www.twitter.com/phillipsmedisizYouTube: www.youtube.com/user/PhillipsPlasticsCorpLinkedIn: www.linkedin.com/company/Phillips-MedisizePhillips-Medisize History: www.phillipsmedisize.com/about-us/historyFacebook: www.facebook.com/phillipsmedisizecareers *LI-POST Country:USALocation:Menomonie, WI 54751 Equal Opportunity Employer:We are an equal opportunity employer. Minority/Female/Disabled/Veteran
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Website : http://www.molex.com
As a leading provider of electronic components and solutions, Molex views innovation as a tool for solving complex customer challenges. This philosophy has helped us not only create many pioneering electronic solutions, but also build a globally recognized company. Through standard-setting products, high-performance people and a globally collaborative process, we are committed to anticipating tomorrow's needs and helping our customers engineer breakthroughs that make the world better.