Job Title
QMS Software Validation Engineer
Job Description
Develop project management, leadership and interpersonal skills by driving software validation activities for Philips’ Image Guided Therapy Device (PIGT-D) business unit.
Your role:
Establishes lean practices around quality system non-product software controls for all shared or local QMS software systems in line with applicable policies and procedures.
Ensures that non-product software applications and related infrastructures are validated for their intended use by a controlled and documented process.
Guides non-product software validation activities and ensures results for all phases of the software system lifecycle are properly documented and stored.
Performs uploads/release of part 11 compliant documentation to PLM system.
You're the right fit if:
You’ve acquired 3+ years of experience in medical device or other regulated industry.
Your skills include Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971. Desired understanding of 21 CFR Part 11, GPSV, and GAMP 5
You have a Bachelors degree in engineering or equivalent technical experience.
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 excellent written and verbal communication skills, strong customer service and interpersonal communication skills and the demonstrated ability to partner with the business and effectively interact with and influence employees and managers on all levels.
About Philips
We 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.
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.
Philips Transparency Details
The pay range for this position is $56,700 to $108,864 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.
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 Information
US 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 San Diego, CA; Colorado Springs, CO or Plymouth, MN.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
