Your Job
Phillips-Medisize, a Molex Company, is seeking a Director of Quality to oversee the effective execution of quality systems, representing the business to align with FDA and other regulated bodies, and provide global leadership and direction to the Quality teams globally.
Our Team
Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the commercial, industrial, 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. Autoinjectors and pens for delivering insulin, GLP1, epinephrine and other life-saving drug treatments. Advanced, wearable injection pumps. Point-of-care and at home diagnostic tests. Electrophysiology technology. Continuous glucose monitoring systems.
What You Will Do
- Provide direction and leadership to the Quality teams including people management
- Maintain and improve quality systems to support the Strategic Plan for new business opportunities
- Ensure compliance with medical device and pharmaceutical regulations and quality system requirements
- Work with Commercial team to represent Phillips-Medisize Quality System with customers and potential customers
- Work with management on risk assessment and regulatory compliance
- Drive continuous improvement activities with emphasis on root cause analysis
- Provide expertise for the continuous improvement of the quality system as it pertains to combination products and labeling.
Who You Are (Basic Qualifications)
- B.S. degree in quality, business, or engineering field
- Ten (10) years or more experience in a quality role in a medical device or pharmaceutical industry
- Ten (10) years or more experience in a leadership or management role
- Two (2) years experience at a Director level with experience with cross-functional teams in a complex matrix organization (multiple products/multiple customers)
- Knowledge 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 analysis
- Direct experience leading audits and regulatory inspections
What Will Put You Ahead
- Experience with IATF16949
- Contract Manufacturing Experience
In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.
At 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.
Hiring Philosophy
All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here.
Who We Are
As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
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.
Our Benefits
Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.
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.
Equal Opportunities
Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following website for additional information: http://www.kochcareers.com/doc/Everify.pdf
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