Quality Systems Engineer

What You Will Do

Quality Management System (Core Responsibility)

Manage, maintain, and improve the company’s QMS in alignment with ISO 9001, ISO 13485, AS9100, and internal procedures

Identify gaps or conflicts between SOPs, work instructions, and regulatory requirements—then drive resolution

Support and enhance QMS processes to enable scalability during rapid business growth

Corrective Actions & Problem Solving

Lead and manage corrective and preventive actions (CAPA) from investigation through effectiveness verification

Conduct root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, 8D)

Partner cross-functionally to resolve quality issues and drive sustainable solutions

Audit Management & Compliance

Support planning, execution, and follow-up of internal, external, and customer audits

Prepare documentation, coordinate audit activities, and ensure timely closure of findings

Progress toward independently leading audits and audit programs

Metrics & Continuous Improvement

Develop, track, and analyze quality metrics (e.g., CAPA cycle time, audit findings, nonconformances)

Use data and trend analysis to assess QMS effectiveness and recommend improvements

Drive continuous improvement initiatives across processes and systems

Cross-Functional Collaboration

Work closely with internal stakeholders to support quality initiatives and resolve issues

Partner with Quality team members and broader engineering/manufacturing teams

Contribute to building a proactive, problem-solving quality culture

Additional Details

Travel: Occasional (audit-related; primarily local)

Schedule: Standard business hours

Work Environment: Combination of office and manufacturing floor

What it Takes

Bachelor’s degree in Engineering, Science, or related field or equivalent experience

7–10+ years of experience working within a Quality Management System

Hands-on experience with:

ISO 9001, ISO 13485, and/or AS9100

CAPA processes and root cause analysis

Internal or external audits

Strong analytical and problem-solving skills

Ability to manage multiple priorities in a fast-paced environment

Strong communication skills and cross-functional collaboration experience

Self-starter with a proactive, ownership mindset

Comfortable working in ambiguity and driving structure where needed

Strong systems thinker who can connect process, compliance, and business impact

Confident communicator who can influence across teams

What Sets You Apart

ASQ Certification (e.g., CQE, Certified Auditor)

Experience in manufacturing or regulated industries

Experience developing QMS metrics and performing trend analysis

Experience scaling or improving quality systems in a growing organization

What's in it for You

We offer a competitive total compensation package

In addition, we offer competitive benefits including but not limited to:

Health Insurance: Traditional OR High Deductible plan

Flexible Spending Accounts

Health Savings Account (including employer contributions)

Dental and Vision

Basic and Supplemental Life Insurance

Short-Term and Long-Term Disability

Paid caregiver leave

You will receive PTO + Wellness Hours + Holiday Pay + Volunteer Hours

401k with company match and immediate vest

Employee Stock Purchase Program with a 15% discount

And More!