Getinge

This position will lead Getinge’s Post-Market Surveillance (PMS) program for the Merrimack, NH site for an exciting and diverse portfolio of products.. Oversees and executes the Post-Market Surveillance (PMS) program. Authors Post-Market Surveillance Plans, Post Market Surveillance Reports (PMSR), and Periodic Safety Update Reports (PSUR).. Participate in internal and 3rd party audits as Post-Market Surveillance SME. Minimum of three (3) years of experience with medical device post-market surveillance, design quality engineering, or similar.

surveillance

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. HYBRID: Eligible to work from home 1 - 2 days/week. Job Overview This position will lead Getinge’s Post-Market Surveillance (PMS) program for the Merrimack, NH site for an exciting and diverse portfolio of products. This role will lead a cross-functional team to gather, analyze, and report on post-market data, make recommendations, and initiate actions accordingly. The role will apply risk management principles to all activities. In addition, this role will support other quality initiatives including, but not limited to, support of design control activities, maintenance of risk management files, and continuous improvement initiatives. Job Responsibilities And Essential Duties <ul><li> Oversees and executes the Post-Market Surveillance (PMS) program </li><li> Authors Post-Market Surveillance Plans, Post Market Surveillance Reports (PMSR), and Periodic Safety Update Reports (PSUR). </li><li> Gathers, analyzes, and reports on PMS data within the defined PMS period to ensure compliance with defined frequency requirements. </li><li> Identify, analyze, and interpret trends or patterns in complex data sets. Evaluate the information using sound statistical rationale and objective risk-based decision making </li><li> Owns and leads collaboration with cross-functional PMS Team to define and agree upon recommended actions and/or documentation updates based upon PMS findings (to be reported within the PMSR/PSUR). </li><li> Initiates Corrective Action Requests and other activities, such as design/process changes or Risk Management File updates, based on PMS findings. </li><li> Participates in Management Review and communicates findings to Senior Leadership, including status of PMS activities and escalates quality issues as appropriate. </li><li> Help ensure accurate PMS process procedures are maintained and compliant with applicable standards and regulations. </li><li> Monitor external regulations, standards, guidance documents, and common specifications to identify compliance gaps and maintain compliant PMS processes. </li><li> Provide guidance to product Subject Matter Experts (SMEs) in technical matters related to PMS. </li><li> Identify development and training opportunities for the organization in relation to PMS activities and best practices. </li><li> Participate in internal and 3rd party audits as Post-Market Surveillance SME </li><li> Supports responding to requests for additional information related to PMSRs or PSURs from Competent Authorities, Registries, and Notified Bodies. </li><li> Investigates and evaluates new failure modes when encountered. </li><li> Provide expertise in risk management techniques when assessing post-market data, including complaints, adverse events, and user feedback. </li><li> Contributes to the team effort by accomplishing related tasks as needed. </li><li> Support other quality initiatives including, but not limited to, support of design control activities, maintenance of risk management files, and continuous improvement initiatives. </li></ul>Minimum Requirements <ul><li> Bachelors or Master’s Degree in Engineering or other Scientific or Technical area. </li><li> Minimum of three (3) years of experience with medical device post-market surveillance, design quality engineering, or similar. </li><li> Strong computer skills, including MS Office applications (Word/Excel) are required. </li><li> Strong project management, prioritization and leadership skills are required. </li></ul>Required Knowledge, Skills And Abilities <ul><li> Working knowledge of FDA Quality System Regulations (21 CFR Parts 820 & 822), European Medical Device Regulations (EU MDR; specifically Articles 83, 84, 85 & 86), Canadian Medical Device Regulations (CMDR), Therapeutic Goods Medical Device Regulations (TGA), ISO 13485, ISO 14971, BS EN 62366-1, and other recognized international standards and how they relate to post-market surveillance, design control, risk management, and other quality practices. </li><li> Excellent analytical, problem-solving, and applied thinking skills. </li><li> Demonstrated ability to motivate multi-departmental project teams and resolve quality-related issues in a timely and effective manner. </li><li> Team player with ability to successfully interact with representatives from a variety of disciplines. </li><li> Strong collaboration skills. </li><li> Excellent verbal and written communication skills. </li><li> Experience with statistics, including the ability to acquire, query, and analyze data and interpret results. </li><li> High level of attention to detail and accuracy. </li><li> Demonstrated ability to identify missing information and evaluate accuracy of presented information. </li><li> Ability to prioritize and manage key deliverables in a fast-paced environment. Must be able to handle multiple responsibilities concurrently. </li><li> Knowledge of Good Documentation Practices (GDP) required. </li></ul> Environmental/Safety/Physical Work Conditions <li> Ensures environmental consciousness and safe practices are exhibited in decisions. </li><li> May work extended hours during peak business cycles. </li> This position may require some travel to Getinge or partner sites (<li> May work on-site and remotely, minimum requirement of 3+ days on-site. </li>The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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: <ul><li>Health, Dental, and Vision insurance benefits</li><li>401k plan with company match</li><li>Paid Time Off</li><li>Wellness initiative & Health Assistance Resources</li><li>Life Insurance</li><li>Short and Long Term Disability Benefits</li><li>Health and Dependent Care Flexible Spending Accounts</li><li>Commuter Benefits</li><li>Parental and Caregiver Leave</li><li>Tuition Reimbursement </li></ul>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.

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