Sr. Quality Systems & Compliance Engineer

Department: Quality

Employment Type: Full Time

Location: US-California-San Jose

Compensation: $137,300 - $188,800 / year

Description

We are seeking a Sr. Quality Systems professional to support and continuously improve the effectiveness of the Quality Management System (QMS) within a regulated medical device environment.

This role requires broad QMS experience, strong independent judgment, and the ability to lead cross-functional initiatives with minimal direction. The successful candidate will work across multiple quality system processes to support compliance, improve effectiveness, drive continuous improvement, and strengthen overall QMS performance. The successful candidate will be intellectually curious, bring a continuous improvement mindset, proactively seek better ways of working, and embrace new technologies and tools to improve quality system effectiveness.

The ideal candidate understands how quality system elements interact, can identify risks and opportunities, and is capable of driving practical solutions across a diverse business. This role is primarily focused on site-level QMS effectiveness while participating in multi-site and global quality system initiatives as needed.

Role expectations

• Lead and support key Quality Management System (QMS) processes.
• Drive continuous improvement initiatives that enhance QMS effectiveness and compliance.
• Support activities across CAPA, Nonconformance Management, Internal Audits, Management Review, Document Control, and Training.
• Analyze quality system performance data and identify opportunities for improvement.
• Author and maintain procedures, work instructions, forms, and quality system documentation.
• Provide quality systems guidance, coaching, and support to cross-functional stakeholders.
• Partner with Engineering, Manufacturing, Operations, Regulatory Affairs, and Quality teams to improve process effectiveness and business performance.
• Support site audits, inspection readiness activities, and resolution of quality system issues.
• Participate in multi-site and global quality system initiatives, harmonization efforts, and process improvement projects.

What we're looking for

Education: Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.

Experience:

• Typically 6-10 years of experience in Quality Systems, Quality Engineering, Compliance, or related quality disciplines within the medical device industry.
• Broad experience across multiple QMS processes and quality disciplines.
• Experience conducting internal audits and supporting external audits or regulatory inspections.
• Demonstrated ability to lead cross-functional initiatives and drive actions to completion.
• Experience working within multi-site quality systems preferred.

Skills:

• Strong understanding of Quality Management System principles and practices.
• Knowledge of medical device quality system requirements and industry standards.
• Strong problem-solving, root cause analysis, and risk-based decision-making skills.
• Ability to understand how quality system processes interact and impact overall business performance.
• Ability to work independently, navigate ambiguity, and lead initiatives with minimal direction.
• Leverages data, digital technologies, and emerging tools, including AI-enabled solutions, to drive efficiency and effectiveness.
• Strong communication, collaboration, and influencing skills. Ability to communicate and influence across all levels of the organization.
• Excellent organizational and project management capabilities.
• Ability to mentor and guide teams in quality system compliance and continuous improvement practices.

Complementary Skills:

• ISO 13485 Lead Auditor certification, ASQ Certified Quality Auditor (CQA), or equivalent auditor qualification.
• Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits.
• Experience with electronic Quality Management Systems (eQMS) such as Arena or equivalent.
• Knowledge of risk management methodologies such as ISO 14971, PFMEA, or FTA.
• Lean, Six Sigma, or other continuous improvement training/certification.

Pay Transparency

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate's pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.

For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.

Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.