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 (

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.

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