Sr Corrections & Removals SpecialistAs an experienced medical device quality assurance professional, you will be performing various Corrections and Removal functions related to recall management, including: planning, reporting, tracking, record keeping, and other QMS adjacent tasks as required. You will represent the Sleep and Respiratory Care (SRC) business and Philips to global regulators, customers, and act as a liaison to global Philips markets to plan and execute recall activities.Your role:
Supports the development of processes and plans for executing Corrections & Removals (C&R) and ensures they are adequate to maintain compliance with the applicable regulations and meet the expectations of key stakeholders.
Facilitates C&R by ensuring the coordination and/or creation of C&R file documentation, C&R file completion, and C&R communication to all key stakeholders.
Prepares key documents such as C&R documents, product C&R files and various external or internal reports.
Ensures alignment between risk assessment and management documentation and C&R files.
Monitors and reports on metrics for C&R process execution and generates periodic reports.
Engages with global regulators to resolve formal inquiry on time and as needed.
Includes other tasks associated with QMS management such as audit/inspection or CAPA execution.
You're the right fit if:
You’ve acquired 3+ years of experience in Quality and/or Regulatory functions in Medical Devices or another regulated technical environment.
Your skills include an understanding of 21 CFR Part 820 (QSR), Part 7, 806, 810 and other global regulations associated with recall management; 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 in the quality, regulatory or C&R fields.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
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.
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Philips Transparency DetailsThe pay range for this position in Massachusetts is $89,000 to $153,000.The 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, 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