Find & Apply For Clinical Quality Manager Jobs in Orangeburg, New York

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world. Our Quality Manager supports Mativ's Healthcare & Wellness business. This individual shall provide strong leadership of the site's Quality function, whilst also working collaboratively with other Quality (and Regulatory) personnel within Healthcare & Wellness to support best practice on a global level. The Quality Manager shall develop, maintain and promote a collaborative working relationship between the Quality function and Operations, as well as the appropriate stakeholders throughout the business, in addition to external customers. In this role, the Quality Manager will drive and maintain Quality excellence throughout the site, leading by example and promoting a culture of Quality. The location of this role is Orangeburg, New York, and is an on-site position (not eligible for remote work). This position will report directly to the US Quality Management Team Lead for Healthcare & Wellness.

responsibilities:

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• -Responsible for all aspects of the site's Quality functional areas including Quality Engineering, Quality Control, Quality Inspection and Document Control style="margin-bottom:0.0in;margin-top:0.0px
• -Provide strong leadership and direction to Quality team members, being responsible for all aspects of staff management including training, development, mentoring and coaching.

Set goals and objectives for Quality personnel, ensuring alignment with strategic imperatives. Ensure clear strategies are implemented to develop each role within the Quality function, to facilitate succession planning. style="margin-bottom:0.0in;margin-top:0.0px

• -Key member of the Orangeburg Plant Leadership Team defining, implementing and supporting required growth and improvement projects style="margin-bottom:0.0in;margin-top:0.0px
• -Effective communication with internal and external functions including Regulatory, Operations, Supply Chain, Finance, Health & Safety, Human Resources, Research & Development, Commercial and external partners style="margin-bottom:0.0in;margin-top:0.0px
• -Manage and maintain the Quality Management System to ensure on-going compliance of the Quality System to applicable standards and regulations including

ISO 13845

2016 and

FDA 21 CFR

Part 820, acting as the site's Management Representative style="margin-bottom:0.0in;margin-top:0.0px

• -Lead the Management Review process, reporting to top management on the suitability, adequacy and effectiveness of the QMS at defined intervals and on any need for improvement style="margin-bottom:0.0in;margin-top:0.0px
• -Coordinate and host

Certification Body Audits, Regulatory Agency Inspections and Customer Audits:

management of any necessary follow-up actions, ensuring on-time completion style="margin-bottom:0.0in;margin-top:0.0px

• -Quality oversight of all aspects of product realization: authoring, review and / or approval of associated technical documentation, as applicable style="margin-bottom:0.0in;margin-top:0.0px
• -Consistently promoting awareness of best industry practices throughout the site and making appropriate Quality-related decisions on a daily basis. Provide training on Quality-related topics, where scope for improvement and / or additional support is identified. style="margin-bottom:0.0in;margin-top:0.0px
• -Maintain and improve Quality through ownership of the site's Internal Audit program, by ensuring processes are in-place to gather and monitor feedback relating to customer requirements, by being accountable for the site's customer complaints system, through management of the site's control of non-conforming product process, and by confirming appropriate corrective action is taken to eliminate the cause of non-conformances.

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• -Develop, maintain and monitor Quality Key Performance Indicators (KPIs) and metrics to identify areas for improvement, allowing informed decision-making and measurement of progress over time style="margin-bottom:0.0in;margin-top:0.0px
• -Maintain a customer excellence mindset at all times to achieve customer satisfaction. Manage customer relationships effectively, ensuring appropriate levels of communication. Confirm that customer requirements are appropriately documented (e.g. Quality Agreements) and followed. style="margin-bottom:0.0in;margin-top:0.0px
• -Ensure Quality participation and input into Risk Management activities, including Risk Management tools (e.g. pFMEAs) qualifications: Required style="margin-bottom:0.0in;margin-top:0.0px
• -Bachelor's degree in science or engineering (or equivalent) style="margin-bottom:0.0in;margin-top:0.0px
• -At least 5+ years of experience working within Quality Management, preferably gained within the medical device and / or pharmaceutical industry
• Thorough understanding of ISO 13485 and

FDA 21 CFR 820

• Knowledge of

FDA 21 CFR 210 & 211

• Knowledge of MoCRA Requirements
• Knowledge of

ISO 14971

standard

• Certified Lead Audit qualification
• Substantial front room experience of FDA Inspections and Certification Body Audits Preferred style="margin-bottom:0.0in;margin-top:0.0px
• -Lean Six Sigma Green Belt Certification Competencies style="margin-bottom:0.0in;margin-top:0.0px
• -Demonstrated ability to manage a Quality team in an operational environment
• Strong leadership skills, including change management
• Highly motivated and self-directed to enable success in working in a matrix reporting environment
• Strong communicator (verbal and written): able to clearly communicate to all levels of management
• Detail-orientated, excellent organization skills and diligent
• Strong interpersonal skills, works collaboratively within and across teams

WHAT WE OFFER

Mativ benefits say a lot about how we care for each other. Our employees and their families have many different needs. As a result, our benefits offer choices on many levels and are high in quality, competitive in the marketplace, and affordable.

ABOUT MATIV

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.