WI3654521

1

Bachelor's Degree

Bachelors Degree

Unspecified

40

JOB REQUIREMENTS: 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 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\... For full info follow application link.
\*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/92FAC956DCCE47B0