Senior Quality Manager

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.

What You Will Do :

Lead and direct regulatory FDA and ISO), internal and external (customer) audits within the company to ensure compliance to applicable regulatory and corporate standards / requirements are met.

This includes developing and maintaining an audit schedule, performing internal audits, scheduling personnel to assist with audits, maintaining a list of qualified internal auditors, writing and issuing audit reports, and verifying corrective actions

• Manage a successful CAPA system, including initiation, support of the root cause investigation, closure, and verification of effectiveness
• Develop and analyze trending data for quality systems to determine areas for continuous improvement
• Maintain current knowledge base of regulations, corporate policies, and standards to ensure compliance. Functions as a resource person for matters related to the Quality System
• Report and adhere to quality Key Performance Indicators (KPIs)
• Lead the coordination of continuous improvement processes for the Quality System
• Ensure a high level of internal and external customer service. Provides an excellent customer experience
• Supervise workers engaged in various quality assurance and quality control activities to ensure high productivity and technical integrity
• Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of products
• Expertise in project management and problem-solving skills, including the ability to identify, investigate and resolve technical and / or systemic issues
• Lead and interpret scientific and technical data and translate that into test reports, validation reports, or CAPA
• Mentor, coach, train, and develop employees
• Drive broader quality system improvements across Avalign in collaboration with other Quality Leadership Team members
• Complete other duties as assigned

What You Will Need :

• Bachelor’s degree required, in an engineering or technical field preferred
• 3+ years experience in a Quality Assurance or Regulatory compliance role in the medical device or related industry
• Prior experience in a Quality Manager or similar leadership role preferred
• Experience in ISO 13485 and FDA 21 CFR part 820 requirements
• Ability to travel up to 25%

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