Supervise and support a team of Quality and/or Compliance professionals, ensuring effective execution of quality system processes.
Ensure compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485, and internal quality policies).
Lead and support internal and external audits, regulatory inspections, and customer audits, including preparation, execution, and follow‑up.
Oversee investigation and resolution of nonconformances, deviations, CAPAs, and complaints, ensuring timely and compliant closure.
Review and approve quality documentation such as SOPs, work instructions, protocols, and reports.
Partner cross‑functionally to assess and mitigate quality and compliance risks related to manufacturing, suppliers, and product changes.
Drive continuous improvement initiatives to enhance quality system effectiveness and operational performance.
Coach, develop, and evaluate team members to build technical capability and leadership readiness.

Bachelor’s degree in Engineering , Life Sciences, Quality, or a related technical discipline.
4–6 years of experience in Quality, Compliance, or Regulatory roles within a regulated industry (medical device preferred).
Prior experience leading or supervising employees or project teams.
Strong working knowledge of quality management systems and regulatory requirements.
Experience with audits, inspections, and quality investigations (CAPA, deviations, nonconformances).
Preferred: Advanced degree (MS or equivalent) in a related field.
Preferred: Experience supporting manufacturing operations in a medical device environment.
Familiarity with risk management tools and continuous improvement methodologies (e.g., Lean, Six Sigma).
Experience interacting directly with regulatory agencies or notified bodies.
Strong written and verbal communication skills with the ability to influence cross‑functional partners.
English (required).

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Supervisor, Quality/Compliance

Key skills