This is a position under Sleep & Respiratory Care business unit looking for an experienced medical device Quality Assurance Professional who, under supervision, will be a Senior Corrections and Removals Specialist performing various Post Market functions related to recall reporting, tracking, and process execution.Your role:
Accurate and on time tracking of open SCR Field Actions on a monthly basis
Support Post Market Surveillance group with Competent Authority requests
Collaborate with SRC business and Philips Q&R Market representatives to accurately track and document field corrective actions
Work in SAP to run reports, update and review records, work with vendor(s) to provide accurate customer mailing tracking data that meets regulatory requirements
Support external and internal audit of the reporting group when needed
You're the right fit if:
You’ve acquired 3+ years of experience in Quality and/or Regulatory experience in a medically regulated or technical environment
Your skills include an understanding of 21 CFR Part 820 (QSR), Part 7, 806, 810 (Recalls/Corrections and Removals); experience with TrackWise or SAP, proficiency in Microsoft Excel; strong organizational skills, project management skills strongly preferred
You have a Bachelor’s degree in a technical or scientific discipline or equivalent education/experience
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
You have the ability to work under pressure to meet regulatory reporting periods and company requirements; strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment; have the ability to meet and/or exceed goals; capable of making commitments, setting priorities and delivering results on time; able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives
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.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position in PA is $79,800 to $136,800 annually.The pay range for this position in MA is $89,376 to $153,216 The actual base pay offered may vary 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 (https://www.careers.philips.com/na/en/best-employee-benefits) .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 PittsburghNew Kensington, PA; Murrysville, PA or Cambridge, MA.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