Senior Quality Systems Engineer

Philips International; Bedford, Northern (MA, KY); Hybrid; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO and Paid Time Off

401(k) plan with match

Health Savings Account (HSA)

Education reimbursement

Job summary

Philips in Bedford, MA seeks a Senior Quality Systems Engineer to own and improve the QMS, including audits, document control, training and CAPA. You will analyze QMS metrics, develop SOPs, and lead cross-functional teams to drive compliant, efficient quality processes.

With 5+ years in FDA/ISO 13485 medical device quality, you will mentor engineers, support external audits, and collaborate across stakeholders. This office-based role requires in-person presence three days per week.

Qualifications

• Minimum 5+ years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience with CAPA, audits, document control, training and QMS changes.
• ASQ-CQE or ISO Lead Auditor certifications are desirable.

Responsibilities

• Owns quality processes including audits, document control, training and CAPA to ensure QMS compliance.
• Analyzes QMS metrics and prepares reports for senior management.
• Develops and revises SOPs, work instructions, and quality manuals.
• Leads cross-functional problem-solving and root cause analysis to implement lasting solutions.
• Prepares for external regulatory audits and responses to findings.

Skills

Quality management

Audits

CAPA

Document control

Training

KPI analysis

Cross-functional leadership

Root cause analysis

Mentoring

Education

Bachelor’s Degree in Quality, Engineering or similar

ASQ-CQE

ISO Lead Auditor certification

Job description

Senior Quality Systems Engineer### Job DescriptionThe 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.**Additional Information:*** US work authorization is a precondition of employment. *T**he 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. Interested candidates are encouraged to apply as soon as possible to ensure consideration.