Senior Quality Systems Engineer

About the role

The 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.

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.
• 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.

Requirements

• A minimum of 5+ years’ experience in FDA regulated (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.
• Experience managing/maintaining training metrics/matrix.
• Proven experience leading cross-functional teams and the ability to mentor less experienced engineers.
• Detailed experience/knowledge in CAPA processes, including problem identification, root cause analysis/tools, implementation of solutions to prevent recurrence and drive continuous improvement.
• 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.
• Able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.

Qualifications

• A minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
• ASQ-CQE, ISO Lead Auditor certifications-desired.

Skills

• Specialized knowledge in breadth and/or depth to a variety of issues and projects within the team.
• Data analysis skills.
• Understanding of QMS metrics/key performance indicators (KPI).
• Effective communication and relationship-building skills.
• Leadership and mentoring abilities.
• Structured problem-solving and root cause analysis skills.

Benefits

• Comprehensive Philips Total Rewards benefits program, including a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

Pay

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.

Schedule

This is an ON-SITE role. Employees are required to work in the company's facilities at least 3 days per week.

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%.