Quality Engineering Manager Jobs

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 Engineering Manager is responsible for implementing, leading, and maintaining the organization’s quality system within a manufacturing environment.

What You’ll Do:

• Perform internal audits as required
• Maintain and continuously improve Avalign processes and quality systems to ensure production of compliant product
• Ensure effective corrective/preventive action processes
• Oversee improvement projects related to manufacturing and inspection processes
• Assist management as requested on special projects
• Lead, or participate in, customer satisfaction and employee involvement activities
• Ensure maintenance of KPI (key performance indicators)
• Supervise the Quality Control Department
• Manage the quality aspects of the New Product Introduction (NPI) process
• Interface with FDA and other agencies as required
• Develop and implement new inspection methods / methodology

What You Won’t Do:

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

Who You Are:

• Accept assignments with open, cooperative, positive and team-oriented attitudes
• Able to plan and execute plans across teams
• A self-starter who thrives in a fast-paced environment
• Effective communicator, both written and verbal
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable worker who knows the importance of showing up when it counts

What You’ll Need:

• 3-5 years’ experience in medical device manufacturing
• 3-5 years’ of supervisory experience
• Knowledge and experience with FDA regulations and ISO 13485 2016
• Bachelor’s Degree in Engineering or science discipline preferred

What You’ll Enjoy:

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

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.

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