This is an exciting opportunity to be a part of the Post-Market Surveillance team. The Post-Market Surveillance and C&R role involves monitoring the safety and effectiveness of medical devices after release to the market.Your role:
Executing post-market product data analysis processes in support of Product Quality Safety Surveillance Data Review and providing post-market surveillance data in support of regulatory health authority requests, root cause investigations, and new product development.
Ensuring the adequacy of the documentation of post-market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required. Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.
Reviews and continuously executes the global post-market surveillance process. Extracts monthly post-market quality data and maintains compliant records. Performs post-market safety and surveillance activities including data analysis, tracking/trending, and signal detection.
Evaluates Safety Signals through data analytics, adverse event reporting, Non-Conformance Reports, Corrective Actions/Preventative Actions, Customer Feedback. Responsible for summarizing trends, signals, and escalations.
Executes filing of appropriate post-market, safety surveillance-related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures. Completes projects/other duties as assigned. Provides support during external and internal audits of the post-market surveillance processes.
You're the right fit if:
You’ve acquired 7+ years of medical device and/or other regulated industry (pharma, IVD) experience.
Your skills include 1+ years of experience with data analytics or computer science and at least a Bachelor's degree in a science or engineering discipline.
You have 1+ years of experience with CAPA, as well as global medical device regulations and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
1+ years of experience with quality systems, quality tools and methodologies, including Critical to Quality, FMEA, Root Cause Analysis, Pareto, 8-D, 5 Why, Audit training, skills, or willingness to learn experience with auditing suppliers.
How we work togetherWe believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.This is an office role.About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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Philips Transparency DetailsThe pay range for this position in Massachusetts is $89,376 to $153,216The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge, Massachusetts.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran