CAPA Engineer

Develop project management, leadership and interpersonal skills by driving CAPA activities and CAPA process improvements for Philips’ Image Guided Therapy Device (PIGT-D) business unit.Your role:

Facilitating product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

Project managing all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

Representing CAPAs during audits and CAPA Review Board meetings.

Leading and mentoring cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

Analyzing quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

Working effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.

Independently producing and completing CAPA records.

Performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.

You're the right fit if:

You’ve acquired 3+ years of experience in medical device or other regulated industry

Your skills include working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971; ability to understand and analyze complex problems, including software and hardware design issues; demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations; strong Project Management skills, including ability to project manage all CAPA activities; ability to analyze data and apply statistical techniques

You have a bachelor’s degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence

You have the demonstrated ability to partner with the business and effectively interact with and influence employees and managers on all levels; you have excellent written and verbal communication skills.

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) .

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)

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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 is $79,800 to $153,216 annually. 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 Colorado Springs, CO; San Diego, CA or Plymouth, MN.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