Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.
At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.
Job Summary:
In this role you will proactively develop, lead, and drive the execution of the quality assurance strategy across the West, Grand Rapids site by overseeing the elements of quality operations, quality control and quality system functions. The position is a key and active member of the Site Leadership Team in West, Grand Rapids and interacts with the team to ensure business objectives are aligned and that the company is performing to operational objectives.
Reports directly to the Director, Quality Operations..
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.
Reporting to the Director, Quality Operations, the role will play a critical part in the company's business planning / strategy development.
Lead the Quality function for medical device products and components moulded, assembled, and packed by West, Grand Rapids.
The role will also have a dotted line reporting relationship to the Director, Operations, Grand Rapids 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 the Director, Quality Operations.
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. Chairing customer meetings with respect to Quality standards and expectations.
Directs the West Grand Rapids Quality functions, such as Operations QA, Validation QA, Supplier QA, QA Programs, Systems, Microbiology and Metrology, to ensure all product are developed, manufactured, tested, stored, and distributed in accordance with regulatory, customer and West standards, guidelines and procedures
Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines
Directs West, Grand Rapids QA in line with Sister Site agreement requirements for products manufactured at Grand Rapids on behalf of other West sites
Oversee regulatory agency interaction related to compliance to local and regional guidelines/ regulations
Develop strong internal and external relationships with regulatory bodies and authorities
Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
Responsible for developing a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis in accordance with ISO 14971.
Establish, monitor, and report on appropriate Key performance indicators which underpin the performance of West, Grand Rapids 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
Ensures West, Grand Rapids has an internal audit program, supplier audit program and all audits are conducted to drive improvements and achieve site KPIs
Play a role as a key contributor to Global Enterprise Quality documentation updating, including where appropriate, leading any updates.
Participate in and drive... For full info follow application link.
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a disability or special need that requires accommodation, please send an email to [email protected].
