Quality Manager

Avalign Technologies•Akron, OH

11d

About The Position

Avalign is seeking a Quality Manager to lead the oversight and integrity of the site Quality System and establish product quality and compliance strategies. The role serves as a liaison between the company and governmental agencies, notified bodies, and customers to ensure compliance with quality and regulatory standards. The Quality Manager directs site quality employees and oversees quality assurance, quality control, and regulatory compliance activities. The position may also support broader quality system improvements across Avalign in collaboration with the VP of Quality & Regulatory and other site Quality Leadership Team members.

Requirements

Bachelor’s degree; engineering or science preferred.
Five or more years of management experience in quality assurance and/or an engineering discipline preferred.
At least three years of quality experience in the medical device industry.
Excellent leadership skills.
Ability to lead quality project management and present problem resolutions.
Ability to listen effectively and communicate through various modes with employees at all levels.
Proficient written and technical communication skills.
Ability to set and achieve challenging goals and persist through obstacles.
Treat others with respect and consideration regardless of status or position; accept responsibility and follow through on commitments.
Demonstrate accuracy and thoroughness, promote quality, apply feedback to improve performance, and monitor one’s own work.
Ability to plan and execute plans across teams.
Effective written and verbal communication.
Self-starter able to thrive in a fast-paced environment.
Quick learner willing to develop knowledge of manufacturing processes.
Reliable and able to accept assignments with an open, cooperative, positive, and team-oriented approach.

Nice To Haves

Engineering or science degree.
Five or more years of management experience in quality assurance and/or an engineering discipline.

Responsibilities

Direct, coordinate, and evaluate site quality employees, including hiring, training, assigning and directing work, performance appraisal, employee recognition and discipline, and resolution of complaints and problems.
Act as the site Management Representative for the Quality System.
Lead regulatory, internal, and customer audits, including notified body, unannounced, and government audits or inspections; ensure timely follow-up on recommendations and audit nonconformities.
Manage the CAPA system, including initiation, root-cause investigation support, closure, and verification of effectiveness.
Manage the site Management Review process.
Track and report site Quality Objectives and Quality KPIs.
Coordinate continuous improvement processes for the Quality System.
Lead customer communications and problem-solving related to customer requirements during manufacturing transfers for NPI or complaint investigations.
Maintain current knowledge of regulations, corporate policies, and standards, and serve as a resource on Quality System matters.
As assigned, drive broader Avalign quality system improvements with the VP of Quality & Regulatory and other site Quality Leadership Team members.
Provide a high level of internal and external customer service.
Supervise workers performing quality assurance and quality control activities to support productivity and technical integrity across sustaining and new product introduction quality teams.
Mentor and train site employees on quality concepts, including employees outside the direct reporting structure as needed.
Manage site quality assurance efforts and site regulatory compliance issues.
Maintain the Quality System, including systems for internal and external inspection of purchased raw materials and finished items, as well as production operations and processes.
Collaborate with cross-functional colleagues to achieve applicable standards and regulations.
Plan and accomplish goals using experience and judgment.
Lead quality project management and present problem resolutions.