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.

This role requires the candidate to lead the oversight and integrity of the Quality System and establishes product quality and compliance strategies. The role also acts as a liaison between the company and various governmental agencies, notified bodies, and Avalign customers to assure compliance to all quality and regulatory standards.

What You’ll Do: Responsible for the overall direction, coordination, and evaluation of quality employees for worksite. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include

interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems Acts as the site Management Representative for the site quality system. Leads and directs regulatory audits (including notified body, unannounced audits, any government body audits/inspections), internal audits, and customer audits to ensure compliance to applicable regulatory and corporate standards/requirements.

This includes the timely follow-up to any audit recommendations or observed audit nonconformities. Manages the CAPA system, including initiation, support of the root cause investigation, closure, and verification of effectiveness. Manages the site Management Review process. Responsible for tracking and reporting site Quality Objectives and Quality Key Performance Indicators (KPIs).

Assists in the coordination of continuous improvement processes for the Quality System. Lead customer communication and problem solving related to issues with customer requirements during the Manufacturing Transfer for NPI or complaint investigations. Maintains current knowledge base of regulations, corporate policies, and standards to ensure compliance.

Functions as a resource person for matters related to the Quality System. May be tasked with driving broader quality system improvements across Avalign in collaboration with the VP of Quality & Regulatory and other site Quality Leadership Team members. Ability to ensure a high level of internal and external customer service.

Ability to supervise workers engaged in various quality assurance and quality control activities to ensure high productivity and technical integrity, including both sustaining and new product introduction quality teams Relies on experience and judgment to plan and accomplish goals. Mentoring and training employees at the site on quality concepts, both those employees in a direct reporting relationship and as needed to employees in other departments at the site.

Manages site quality assurance efforts and is responsible for all site regulatory compliance issues. Maintains quality system through establishing a system for internal and external inspection of raw materials and finished items purchased and production operations and processes Collaborates with cross-functional colleagues to ensure achievement of standards and regulations What You’ll Need: Bachelor’s degree, engineering or science preferred Five (5) or more years management experience in quality assurance and/or engineering discipline preferred Minimum of three (3) years’ experience in a medical device industry in quality.

Position requires excellent leadership skills. To perform the job successfully, an individual should demonstrate the following competencies Designs workflows and procedures; generates creative solutions; translates concepts and information into images; uses feedback to modify designs; applies design principles and demonstrates attention to detail Ability to lead quality project management and present problem resolution Ability to listen effectively and utilize various modes to communicate with employees at all levels Possesses a proficient written and technical communication skillset Sets and achieves challenging goals and is persistent to overcome obstacles.

Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions and follows through on commitments. Demonstrates accuracy and thoroughness to improve and promote quality; Applies feedback to improve performance; and monitors own work to ensure quality. 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.