Senior Quality Systems Engineer

Philips International; Tennessee; On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

401k matching

Health insurance

Education reimbursement

Stock purchase plan

Job summary

Philips is seeking aSenior Quality Systems Engineer to ensure a compliant QMS across audits, CAPA, document control, and training. You will analyze QMS metrics, develop and revise SOPs, and lead risk assessments to minimize regulatory risk.

The role requires deep regulatory knowledge and a track record in medical device quality operations. You will mentor engineers, drive continuous improvement, and work with internal and external stakeholders to sustain quality excellence within an office-based

Qualifications

• Minimum 5+ years in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience managing/tracking training metrics.
• Proven ability to mentor engineers and lead cross-functional teams.
• Experience CAPA processes with root cause analysis and preventive actions.
• Strong data analysis skills with KPI reporting.
• Ability to build relationships with stakeholders and suppliers.
• Bachelor’s Degree in Quality/Engineering or similar.
• ASQ-CQE and ISO Lead Auditor certifications desired.

Responsibilities

• Takes ownership of Quality processes including Audits, Document Control, Training, CAPA to ensure a compliant QMS.
• Analyzes QMS metrics and prepares detailed trend/variance reports for senior management.
• Develops, implements and revises QMS processes, SOPs, work instructions, and quality manuals.
• Performs risk assessments to identify regulatory/compliance risks and mitigation strategies.
• Drives continuous improvement initiatives to enhance quality and operational excellence.
• Leads cross-functional problem-solving sessions using root cause analysis.

Skills

Audits

Document Control

CAPA

Training metrics

Cross-functional leadership

Data analysis

Regulatory knowledge

Education

Bachelor's Degree

Tools

ASQ-CQE

ISO Lead Auditor

Job description

Senior Quality Systems Engineer

The Senior Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards.

Key Responsibilities

• Takes ownership of Quality processes including-Audits, Document Control, Training, CAPA etc. ensuring that QMS is efficient and meets the regulatory requirements.
• Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
• Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
• Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
• Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and providing responses to audit findings in collaboration with stakeholders.

Right Fit

• You have a minimum of 5+ years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments, with a focus on QMS compliance, documenting QMS changes, gap assessments, Audits, Document Control, Training, CAPA’s, etc.
• You have experience managing/maintaining training metrics/matrix.
• You have proven experience leading cross-functional teams and the ability to mentor less experienced engineers.
• You have detailed experience/knowledge in CAPA processes, including problem identification, root cause analysis/tools, implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in Data analysis, understanding QMS metrics/key performance indicators (KPI), preparing detailed reports that highlight trends, deviations, areas for improvement, and presenting findings to senior management.
• You’re able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
• ASQ-CQE, ISO Lead Auditor certifications-desired.
• 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 a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) 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-based 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.

Phillips Transparency Details

The pay range for this position in Bedford, MA is $102,480 to $163,968. 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. 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.

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.

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 Bedford, MA. May require travel up to 10%.

#LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Equal Employment and Opportunity

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. Know Your Rights