Quality Control Supervisor

Avalign Technologies; Mentor (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

Paid vacation and holidays

401(k) with company match

Tuition reimbursement

Life and AD&D insurance

STD & LTD insurance

Job summary

Avalign Technologies in Mentor, OH is seeking a Quality Supervisor to lead a dynamic quality team in a fast-paced medical device environment. You will supervise inspectors, calibrations, and document reviews to support daily shipping goals and ERP-driven priorities.

You will ensure training is current, track throughput data, and drive improvements in inspection and containment processes while maintaining a safe, organized work area. Knowledge of ISO-13485 and 21CFR820 is essential.

Qualifications

• Read and interpret blueprints with GD&T knowledge.
• 1–3 years supervising a quality team preferred.
• 2–5 years in a related field preferred.
• Understanding of ISO-13485 and regulatory requirements (21CFR820).

Responsibilities

• Supervise department personnel including inspectors, calibration, and document review to support daily shipping requirements established through the ERP system.
• Ensure department training is completed and current to the latest revision.
• Record throughput and pieces per hour data.
• Strategize with operations to prioritize quality inspections to meet daily, weekly, monthly shipment goals.
• Oversee general housekeeping to provide an organized and safe working environment.
• Complete CAPA as assigned.
• Participate in Daily MRB reviews, ensuring timely reviews and movement of segregated product.
• Perform Gage R&R and capability studies as needed.
• Program automated inspection equipment as needed.

Skills

Blueprint reading

GD&T knowledge

Inspection methods

Team supervision

Communication

Job description

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.

The Quality Supervisor creates a positive, safe, and clean working environment where employees are valued, while promoting continuous improvement of performance within the quality department.

Identify and plan training needs to ensure the professional growth of the employees and to promote continuous education. Monitor and log internal/external quality data as it relates to quality performance. Be proactive in improving processes and systems within the department. Take the lead in resolving personnel issues, coordinating time off, monitoring attendance, performance reviews and disciplinary actions. Manage area to conform to all company policies, procedures, and regulations. Effectively communicates with quality manager, peers, and interdepartmental personnel maintaining a cohesive team environment. Assists with other quality related functions upon managerial request.

What You’ll Do:

• Supervise department personnel that includes inspectors, calibration, and document review to support daily shipping requirements established through the ERP system.
• Ensures department personnel training is completed and current to the latest revision.
• Records and reports throughput and pieces per hour data.
• Strategizing with operations to ensure quality inspections are prioritized effectively to meet daily, weekly, monthly shipment goals.
• Oversees general housekeeping to provide an organized and safe working environment.
• Complete CAPA as assigned.
• Participate in Daily Material Review Board (MRB), ensuring timely reviews and movement of segregated product.
• Perform Gage R&R and capability studies as needed.
• Program automated inspection equipment as needed.

What You’ll Need:

• Ability to read and interpret blueprints as well as have a basic Knowledge of GD&T, and Inspection methods.
• One to three years Supervising a quality team preferred but not required.
• Two to five years of experience in a related field preferred but not required.
• An understanding of quality standards (ISO-13485) & regulatory requirements (21CFR820)
• Possess effective communication skills and interact in a professional courteous manner with all co-workers.

What You Won’t Do:

• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs

Who You Are:

• A self-starter who thrives in a fast-paced environment
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable individual who knows the importance of showing up when it counts
• Someone who accept assignments with an open, cooperative, positive and team-oriented approach
• Someone who is able to plan and execute plans across teams
• An effective communicator, both written and verbal

What You’ll Enjoy:

• 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
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.

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.