Quality Systems Manager Medical Devices (ISO 13485/21 CFR 820)

Avalign is hiring a Quality Systems Manager for our Schaumburg IL facility.

A day in this role

Start your day aligning the audit calendar with FDA and ISO expectations confirming internal auditor availability and prepping teams for upcoming customer visits. By mid-morning youre leading an internal audit documenting observations issuing a concise report and tracking corrective actions through closure. After lunch youre reviewing CAPA investigationstesting root-cause theories confirming verification-of-effectiveness plans and ensuring timelines stay on target. Youll analyze trending data from the Quality System to pinpoint improvement opportunities review KPIs and coordinate cross-functional projects that elevate reliability and compliance. Before you wrap youll mentor team members answer technical questions on validations and test reports and connect with other Avalign Quality leaders to drive network-wide improvements.

How youll make an impact

• Own internal external (customer) and regulatory audits (FDA ISO). Build and maintain the audit schedule assign qualified internal auditors conduct audits publish reports and verify corrective actions to completion.
• Run a robust CAPA program: initiate cases guide root-cause investigations close actions on time and confirm effectiveness.
• Mine and trend Quality System data to surface risks and drive continuous improvement across processes.
• Serve as the site resource on regulations corporate policies and standards; keep the team current and compliant.
• Track and communicate Quality KPIs; ensure teams execute to targets.
• Coordinate continuous-improvement initiatives that strengthen the Quality System.
• Champion internal and external customer servicedeliver an excellent experience with every interaction.
• Lead and develop QA/QC staff; safeguard productivity and technical rigor.
• Apply statistics and product specifications to establish standards and reliability expectations.
• Lead complex problem-solving and project management to resolve technical or systemic issues.
• Interpret scientific/technical data and convert insights into test reports validation documentation and CAPAs.
• Coach train and mentor employees; build capability across the team.
• Collaborate with Avaligns Quality Leadership Team to scale best practices enterprise-wide.
• Perform other related duties as assigned.

What you bring

• Bachelors degree required (engineering or technical discipline preferred).
• 3 years in Quality Assurance or Regulatory Compliance within medical devices or a closely related industry.
• Leadership experience in a Quality Manager or similar role preferred.
• Hands-on experience with ISO 13485 and FDA 21 CFR Part 820.
• Ability to travel up to 15%.

Who thrives here

• Self-starters who enjoy a fast pace and variety.
• Curious learners eager to deepen manufacturing process knowledge.
• Reliable team players with a positive cooperative approach.
• Strong planners who can align and execute across teams.
• Clear communicatorswritten and verbal.

What you wont experience

• Stagnationgrowth and learning opportunities are built in.
• Monotonyour product mix keeps every day fresh.
• Feeling like a numberwere close-knit and have each others backs.

Benefits and rewards

• Competitive pay and comprehensive benefits.
• Medical dental and vision coverage.
• Paid vacation plus 10 paid holidays each year.
• Employer-funded Basic Life and AD&D.
• Employer-funded Short-Term and Long-Term Disability.
• Tuition reimbursement.
• 401(k) with company match.
• Generous employee referral bonus program.
• Performance-based culture with promotion-from-within and real career advancement.
• Temperature-controlled environment.
• Community involvement and giving back.
• Additional resources such as travel assistance and EAP.

Technical fluency

• GD&T quality inspection ISO 13485 and quality control methods.
• Precision measurement and hand metrology; advanced inspection and gage techniques.
• Quality control data analysis.

Tools & technologies

• Optical comparator
• Coordinate Measuring Machine (CMM)
• Measurement gauges
• Calipers and micrometers