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Director of Quality
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Director of Quality
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Director Quality - Hudson, United States - PHILLIPS-MEDISIZE MAGNESIUM MOLDING
4 weeks ago
Description
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, 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.
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:
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