Regional Quality Manager

Your Job:

Phillips-Medisize, a Molex Company, is seeking a Regional Quality Manager to lead a team responsible for Global Supplier Quality and the Wisconsin Calibration and Environmental Monitoring teams. This leader is responsible for maintaining and improving the supplier quality, calibration, and environmental monitoring programs to ensure that we meet or exceed the company's stringent requirements for safety, efficacy, and regulatory compliance in accordance with 21 CFR Part 820, ISO 13485, and MDSAP. This role is also a critical piece of our Quality organization's development program where we seek to prepare leaders for roles with increasing responsibility by helping them gain broad experiences across the Quality Organization and within the company.

Location: Hudson, WI (Flexible)

What you will do:

* Maintain and improve a risk-based supplier qualification and monitoring program in accordance with ISO 13485, 21 CFR Part 820 and internal standards.

* Drive supplier performance through metrics and continuous improvement.

* Support external customer, competent authority, and notified body audits as needed within designated sites.

* Develop and execute a continuous improvement strategy within the Calibration and Environmental monitoring teams.

* Lead and participate in company-wide strategic initiatives aimed at improving quality, customer engagement, operational efficiency, and financial performance.

* Interface with manufacturing, engineering, customer service and other functional areas.

Who you are (Basic Qualifications):

* B.S. degree in quality, science, business, engineering field or other technical field with minimum of 4-6 years of experience in a quality role. Management experience is preferred.

* Experience maintaining quality systems and procedures related to existing and emerging regulations.

* Thorough knowledge of FDA and EU international regulations and ISO standards related to manufacturing (e.g. 21CFR, EU MDR, ISO 9001, ISO 13485, ISO 14971).

* Advanced knowledge of quality tools such as; statistical process controls (SPC), design of experiments (DOE), and root cause analysis.

* Direct experience with audits and inspections by regulatory authorities.

Skills and Abilities:

* Advanced decision making and prioritization skills

* Data analysis and project management skills

* Effective and professional written, verbal and interpersonal communication skills

* Ability to travel (<25%) between facilities and to customer locations

This position does not qualify for VISA sponsorship.

LI-SD5

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.

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