Quality Systems & Regulatory Compliance Manager (Medical Devices)

Lead Quality Systems That Power Life-Changing Devices

At Avalign, we design, engineer, and manufacture innovative, high-performance medical devices. Our fast-growing team takes pride in building custom solutions that help clinicians and the patients they serve. You'll join a collaborative environment where quality isn't a step in the process—it is the process.

A Day in the Role

As the site owner for our Quality Management System, you set the vision for quality and align it tightly to company and corporate objectives. You translate regulations into actionable strategies, serve as our Management Representative, and are the point of contact for notified bodies and regulatory agencies. Your leadership ensures our products meet internal standards, ISO requirements, and applicable governmental regulations—while delivering satisfaction for every customer.

How You'll Make an Impact

• Define the site's quality objectives and connect them to broader business priorities.
• Build, implement, and continuously improve quality assurance programs, policies, procedures, controls, and processes to maintain compliance with company standards, ISO, and regulatory guidelines.
• Act as the Quality Systems Management Representative for the site and maintain the effectiveness of the QMS.
• Represent the site during interactions with outside regulatory and notified bodies.
• Interpret governmental regulations and agency guidance; drive compliant implementation across the site.
• Lead quality assurance initiatives and own regulatory compliance matters.
• Create and direct quality programs covering methods, devices, and controls.
• Maintain a robust quality system by establishing internal and external inspection for raw materials, purchased and finished items, and production operations/processes.
• Design the quality organization structure; coach, mentor, and develop team members.
• Collaborate cross-functionally to meet standards, specifications, and regulations.
• Lead both sustaining and new product introduction quality teams.
• Provide full supervisory leadership for quality employees: interviewing, hiring, training, planning, assigning, evaluating performance, rewarding, disciplining, and resolving employee concerns.
• Other duties as assigned.

What You Bring

• Bachelor's degree (engineering or science preferred).
• 5+ years of management experience in quality assurance and/or engineering.
• At least 3 years of quality management experience in the medical device industry.
• Proven leadership strength and the ability to drive outcomes.
• Process-minded creativity: design workflows and procedures; generate inventive solutions; apply design principles and attention to detail; translate concepts and information into visuals when needed and iterate based on feedback.
• Project leadership in quality, with skill in presenting problem resolution and results.
• Clear, adaptable communication across all levels; strong written and technical communication.
• Goal-oriented persistence; follows through and overcomes obstacles.
• Respectful, accountable, and consistent in commitments.
• Accuracy and thoroughness in execution; seeks and applies feedback; self-monitors for quality.

What You Won't Experience Here

• Feeling stuck—growth and learning opportunities abound.
• Monotony—our product variety keeps every day fresh.
• Being just a number—we're a close-knit team that supports one another.

Who Thrives in This Role

• Self-starters who excel in fast-moving environments.
• Curious learners eager to deepen knowledge of manufacturing processes.
• Dependable teammates who show up when it counts.
• Collaborators who take on assignments with a positive, team-first mindset.
• Planners who can execute across teams and timelines.
• Confident communicators—both written and verbal.

Rewards and Benefits

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Work in a thriving, performance-based company that promotes from within
• Temperature controlled environment
• Community involvement—investing in and giving back
• Additional free resources such as travel assistance, EAP, etc.

Compliance Notices

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.