Director, Quality Operations - Merrimack, Nh

At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.
Are you looking for an inspiring career? You just found it.
Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.
We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.
We currently have an opening for a Director Quality Operations supporting our Vascular business. This position provides oversight of Quality Operations, Production Quality Engineering, Design Quality Engineering, Supplier Quality Engineering, Quality Control, Compliance and other Quality Assurance groups.
Job Responsibilities

• Develops and implements the strategy for the provision of all Design and Production Quality Engineering, Supplier Quality, Quality Control and Compliance functions.
• Designated as Management Representative for Quality and Compliance.
• Appointed as person responsible for Regulatory Compliance (PRRC) for Merrimack site to ensure compliance that the reporting obligations referred to in Articles 87 to 91 are fulfilled, in order to comply with Article 15 of European Union Medical Device Regulation (EU MDR) (Regulation EU 2017/745 of the European Parliament.
• Prioritizes Quality Engineering and Quality Control activities to support the production floor, R&D projects, Supplier Quality, Sustaining Engineering projects, CAPA's and projects.
• Manages the quality leadership team to include staffing, training and development succession and salary planning.
• Provide technical leadership, participates in and represents the quality Engineering functions, Quality Control and Quality Assurance during audits by Regulatory Authorities and third party governing bodies.
• Mentors, provides direction, oversight, training & development for engineering staff to ensure compliance to external standards and internal standards and procedures.
• Provides technical expertise in risk management and analysis, statistical techniques, design controls and production controls to facilitate efficient thorough closed loop processes.
• Works with site leaders to coordinate site priorities and resourcing.
• Contributes to the team effort y accomplishing related tasks as necessary.

Required Skills and Abilities

• Bachelors or Master's degree in Engineering or Sciences or equivalent work experience. MBA and ASQ certification preferred.
• A minimum of five years' experience in Quality Engineering in the medical device industry along with three years' experience in Quality Engineering Management leading people leaders required.
• Experience in related engineering areas, Production and/or Design Quality Engineering, CAPA/s and Non Conformance required.
• Strong computer skills, including Minitab statistical software and MS Office applications (Word/Excel) including Microsoft Project.
• Experience in medical device manufacturing environment
• Experience with ISO 13485 certified and FDA QSR compliant Quality Systems
• Experience with ISO 14971, 10993,14630 and 11607
• Excellent problem solving and interpersonal skills.

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About us
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise 'Passion for Life' close to heart.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.