Quality Systems Engineer

Philips

Plymouth, MN(remote)

JOB DETAILS
SALARY
$96,000–$134,500 Per Year
SKILLS
Auditing, Business Growth, Business Processes, Business Support, Case Report Form (CRF), Change Management, Code of Federal Regulations, Compensation and Benefits, Data Analysis, Environmental Work, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Healthcare Quality, ISO (International Organization for Standardization), ISO 9001, Industrial Engineering, International Business, Maintain Compliance, Mechanical Engineering, Medical Equipment, Quality Engineering, Quality Management, Quality System Requirements (QSR), Regulatory Compliance, Regulatory Requirements, Reimbursement, Risk, Stock Purchase Plans, System Integration (SI), Systems Engineering, Systems Maintenance, Trend Analysis, Windchill PLM Software
LOCATION
Plymouth, MN
POSTED
30+ days ago

Job Title

Quality Systems Engineer

Job Description

Quality Systems Engineer

Support business and site level aspects of the quality management system for the Philips Image Guided Therapy Devices business. You will support sites within this business in continuous maintenance and improvement of the Quality Management System and its subsystems.

Your role:

  • Supporting and maintain Quality Management Systems to meet FDA 21CFR820 (QMSR), ISO13485, MDSAP, and other regulatory requirements as applicable for the site. Systems include (but not limited to): Change Management; Document and Record Control; CAPA; Audits; Training; Data Analytics and Trending; Management Review.
  • Support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth.
  • Support the respective QMS architecture and processes.
  • Support and sometimes execute change notices within the Document Controls system (Windchill) ensuring appropriateness and effectiveness.
  • Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies. Identify and investigate potential trends for improvement initiatives.

You're the right fit if:

  • Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • You've acquired 3+ years of experience in Quality Management Systems, Regulatory Compliance, Auditing with medical device or a regulated industry, preferred.
  • Your skills include proficiency in of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP).
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

How we work together

We 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 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.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Learn more about our culture.

Philips Transparency Details

The pay range for this position in Plymouth, MN is $96,000 to $134,500 Annually.

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 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 Plymouth, MN.

#LI-PHI

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 including Disability/Vets and maintains a drug-free workplace.

About the Company

P

Philips

At Philips, we don’t need employees. We need people.

Our goal is to improve the lives of 3 billion people a year by 2025 through innovation that is designed for people, by people. People like you. And we know that in order to be truly innovative, it requires you to make your career personally meaningful. To bring what matters to you in life to everything you do in your career. If you're passionate about improving lives, and have more to offer than just lines on your resume, we want to find a home for you at Philips.

As a diversified health and well-being company, we focus on professional and consumer markets across three interconnected sectors: Healthcare, Consumer Lifestyle, and Lighting. Today, we're a global innovation leader - the first to bring the commonly used CD and DVD products to market, the ones saving lives daily with our imaging systems and patient monitors, and the ones responsible for the lighting of the annual Times Square ball. We aim to improve peoples’ lives every day through meaningful innovations and are the best place to work for those who share our passion for improving lives.

Philips’ people first culture and commitment to providing unlimited possibilities to develop one's career in the directions to which they aspire demonstrates a dedication to inspiring good people, not just hiring employees. At Philips, employees enjoy contributing to cutting edge solutions that truly improve lives, allowing them to 'do good' while doing great and create a legacy in life through their work.

If you are interested in putting your personal skills & passions to work towards improving lives, apply now or learn more at philips.com/na/careers. You can also opt-in to receive updates on future career opportunities and company updates through Philips’ Talent Community, and follow @PhilipsJobsNA on Twitter.



COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1933
WEBSITE
http://www.philips.com/na/careers