Senior Quality Systems Engineer

Mass Digital Health; Massachusetts; On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO and benefits

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Total Rewards program

Job summary

Philips in Bedford, MA is seeking a Senior Quality Systems Engineer to own the QMS, audits, document control and CAPA processes, ensuring compliance with FDA/ISO13485 standards. The role analyzes QMS metrics, prepares detailed reports for senior management, and drives continuous improvement across processes, SOPs, and quality manuals with cross-functional teams.

You will lead training initiatives, manage risk assessments, and collaborate with suppliers and internal stakeholders to maintain

Qualifications

• 5+ years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience managing/maintaining training metrics/matrix.
• Proven experience leading cross‑functional teams and mentoring engineers.
• Detailed CAPA experience including root cause analysis and corrective actions.
• Experience in data analysis and presenting KPI reports to management.
• Ability to build relationships with supervisors and stakeholders.
• Bachelor’s Degree (Required) in Quality, Engineering or similar; ASQ-CQE and ISO Lead Auditor certifications desirable.
• Must meet minimum physical, cognitive and environmental job requirements.

Responsibilities

• Own quality processes including audits, document control, training, CAPA to ensure QMS efficiency and regulatory compliance.
• Analyze QMS metrics and prepare reports for senior management, highlighting trends and deviations.
• Develop, implement and revise QMS processes, SOPs, work instructions, and quality manuals.
• Conduct risk assessments and develop mitigation strategies to minimize regulatory and quality risks.
• Participate in continuous improvement initiatives within the QMS.
• Apply specialized knowledge to drive innovative solutions across projects.
• Participate in training to stay updated on quality standards and QMS procedures.
• Cultivate relationships with internal and external partners and stakeholders.
• Lead cross-functional problem-solving sessions using root-cause analysis and implement solutions.
• Prepare for and participate in external regulatory audits; respond to audit findings.

Skills

Quality Management Systems

Audit leadership

CAPA management

Data analysis

Cross-functional leadership

Training metrics

Root cause analysis

Education

Bachelor’s Degree in Quality/Engineering

Job description

Job Title

Senior Quality Systems Engineer

Job Description

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.

Your role:

• 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.
• Participate 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 provide responses to audit findings in collaboration with stakeholders.

You're the right fit if:

• 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.

Philips 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.

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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%.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.