Your JobPhillips-Medisize, a Molex Company, is seeking a Director of Quality to oversee the effective execution of quality systems, representing the business to align with global regulations and provide global leadership and direction to the sustaining Quality teams across Europe and Asia.Our TeamPhillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries. The largest pharmaceutical, MedTech and in‑vitro diagnostic companies in the world count on Phillips‑Medisize to bring their breakthrough ideas and innovative branded products to market – with confidence. As a contract design and manufacturing organization (CDMO), we work closely with our customers to deliver proven, highly engineered products that help millions of people live healthier, more productive lives.What You Will DoProvide direction and leadership to the cross functional, multicultural Quality teams including people management in Ireland, Poland, Finland, China and Thailand.Maintain and improve quality to support the Strategic Medical Plan for new business opportunitiesCultivate and “audit ready” culture and ensure compliance with all medical device and pharmaceutical regulations and quality system requirements.Work with Commercial team to represent Phillips‑Medisize Quality System with customers and potential customers.Drive continuous improvement activities using tools like Six Sigma, MSA or other statistical methodsManage and improve Key Performance Indicators (KPIs)Who You Are (Basic Qualifications)B.S. degree in quality, business, engineering field or other technical fieldTen years or more experience in a quality roleFive years or more experience in a management roleStrong preference for regional or multi‑site responsibilities.Experience in Medical discipline/industryKnowledge of FDA and international regulations and ISO standards related to medical device design and manufacturing (e.g. MDR, 21 CFR 11, 820, 211 and ISO 13485, 14971)Experience using quality tools, such as SPC, design of experiment (DOE), root cause analysisDirect experience with audits and pre‑approval inspections by regulatory authoritiesWhat Will Put You AheadExperience working with SAP systemsMultilingualAt Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.Who We ArePhillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi‑sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
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