Quality Manager - Medical Device

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

 

Job Summary:

 

In this role you will proactively develop, lead, and drive the execution of the quality assurance strategy across the West Phoenix site by overseeing the elements of quality operations for Medical Device, including Quality Assurance and Quality Engineering. Reports directly to the Quality Manager position in Phoenix.

 

Essential Duties and Responsibilities:

 

Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact. 

 

• Lead the Quality function for Medical Device manufacturing at West Phoenix
• The role will also have a dotted line reporting relationship to the Director, Operations, Phoenix to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same.
• Establishing the sites quality strategy in conjunction with the other members of the Site’s Leadership Team and Quality Manager
• Work directly with the Phoenix Quality Manager to ensure compliance of the medical device system.
• Help maintain a hybrid quality management system between contract manufacturing and medical device.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations.
• QA representative participating in customer face to face steering committees and business review which originate from site customer base.
• Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Establish, monitor, and report on appropriate Key performance indicators which underpin the performance of West, Phoenix relative to Quality for Operations, Quality System, Product Development and New Product Introductions
• Responsible for ensuring QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.
• Coach, mentor and lead highly dynamic team members to help achieved the requirements of this position as well as the individual career goals of team members
• Responsible and accountable for quality departmental budget.
• Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and finished medical devices
• Participate in and drive compliance to global harmonization initiatives
• Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.
• Acts as a mentor and coach to the business with respect to Quality knowledge.
• Fosters and encourages shared learning’s across West e.g., system and technology best practices and harmonization / standardization of West Procedures and practices
• Identification and development of talent to include performance management and succession planning (in the West Talent Gateway).
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor.

 

Basic Qualifications:  

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