Danaher Corporation QARA Medical Leader, Newquay in Newquay, United Kingdom
Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.
Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
We are currently seeking a Quality & Regulatory Affairs Manager to oversee a team of 11 at our medical site in Newquay!
The successful candidate will be responsible for developing a team of 5 direct reports as well as being the lead for all relevant functions on the site. They will maintain and develop the QMS & site compliance in accordance with international standards and drive strategy through cross functional teams to ensure that site Quality KPI Metrics are achieved.
What You'll Do:
Provide leadership and technical expertise to site & Business Unit in the implementation of relevant. Quality Systems, improvements and production requirements. This includes licensing partners as well as suppliers.
Maintain QMS to ISO 9001, ISO 13485, FDA 21 CFR Part 820 and other international standards in accordance with BU specific requirements.
Execute field action risk assessment (FARA) actions as directed by Corporate Medical
Implement continuous improvement practices, including appropriate Kaizen events on relevant Quality processes.
Approve plant level change control, including PDR or IPCO, OQ, PQ requirements as applicable to the product.
Apply and maintain specified audit plan based, management of associated corrective actions. Including a Supplier Audit program.
Responsible for Risk Management acc. to ISO 14971 at site level.
Lead plant customer complaint, CAPA and adhere to corporate complaints and reporting procedures.
Responsible for Customer Quality Agreements and Questionnaire completion (anything related to Medical BU including products manufactured at other Pall sites sold by Medical).
Provide QARA support where requested to OEM customers and branded products.
Prepare and rollout plant-specific training; provide corporate QARA training to plant associates.
Develop talent within the QA function through coaching, development plans and training.
Manage site specific QARA organization to meet BU and site goals, clearly defined roles and responsibilities; and develop talent
Who You Are:
Degree qualified in a Quality, Engineering or relevant discipline
Demonstrated ability in a leadership role within a Medical or highly regulated industry.
Proven experience in Quality Management in a Medical or high-volume manufacturing environment.
Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO9001, FDA 21 CFR Part 820, and ISO 13485.
Ability to think and operate strategically.
Excellent interpersonal and communications skills required; experience working in a matrix environment and managing multiple priorities and projects with dynamic timelines to execution.
What we offer:
25 days annual leave Bank holidays (subject to T&Cs)
On-site subsidised canteen
Employee assistance program 3 x Basic salary life assurance
Long service award Pension scheme
Inclusive family parental plan
Electric car scheme
Supportive of career development and training
Relocation Package if appropriate
We also have the myBenefits website which offers access to the following:
Cycle to Work Scheme Dental Insurance
Medical Cash Plan Will Writing Scheme
Dining Cards Discounted Gym Membership
Kids Pass Various Store Discounts
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.