Quality Systems Engineer
Philips International, Minneapolis, MN, United States
Quality Systems Engineer page is loaded## Quality Systems Engineerlocations:
Plymouth, Minnesota, United Statestime type:
Full timeposted on:
Posted Todayjob requisition id:
579710### Job TitleQuality 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 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 .* Discover* Learn more about* Learn more about**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 .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-PHIThis 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.*At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.*It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.**To ensure reasonable accommodations 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.**Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*
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Plymouth, Minnesota, United Statestime type:
Full timeposted on:
Posted Todayjob requisition id:
579710### Job TitleQuality 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 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 .* Discover* Learn more about* Learn more about**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 .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-PHIThis 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.*At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.*It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.**To ensure reasonable accommodations 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.**Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*
#J-18808-Ljbffr