Quality Manager

Avalign Technologies•Akron, OH

10d

About The Position

The Quality Manager leads oversight and integrity of the site Quality System and establishes product quality and compliance strategies. The role serves as a liaison between the company and governmental agencies, notified bodies, and Avalign customers to ensure compliance with quality and regulatory standards. As the site Management Representative, the Quality Manager oversees the Quality System, site regulatory compliance, quality assurance efforts, quality employees, and continuous improvement. The role 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; an engineering or science degree is preferred.
At least five years of management experience in quality assurance and/or an engineering discipline is preferred.
At least three years of experience in quality within the medical device industry.
Excellent leadership skills.
Ability to lead quality project management and present problem resolutions.
Ability to listen effectively and communicate with employees at all levels through various communication modes.
Proficient written and technical communication skills.
Ability to set and achieve challenging goals and persist in overcoming obstacles.
Treats others respectfully and considerately regardless of status or position; accepts responsibility and follows through on commitments.
Demonstrates accuracy and thoroughness, applies feedback to improve performance, and monitors own work to ensure quality.
Ability to design workflows and procedures, generate creative solutions, translate concepts and information into images, use feedback to modify designs, apply design principles, and demonstrate attention to detail.
Ability to provide a high level of internal and external customer service.

Nice To Haves

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

Responsibilities

Direct, coordinate, and evaluate quality employees at the worksite, including interviewing, hiring, training, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints, and resolving problems.
Act as the site Management Representative for the site Quality System.
Lead regulatory audits, including notified body, unannounced, and governmental audits or inspections, as well as internal and customer audits; ensure timely follow-up on audit recommendations and nonconformities.
Manage the CAPA system, including initiation, support of root-cause investigations, closure, and verification of effectiveness.
Manage the site Management Review process.
Track and report site Quality Objectives and Quality Key Performance Indicators (KPIs).
Assist in coordinating continuous improvement processes for the Quality System.
Lead customer communication and problem-solving related to customer requirement issues during Manufacturing Transfer for NPI or complaint investigations.
Maintain current knowledge of regulations, corporate policies, and standards to ensure compliance, and serve as a resource on Quality System matters.
Supervise workers engaged in quality assurance and quality control activities to support productivity and technical integrity for sustaining and new product introduction quality teams.
Mentor and train site employees on quality concepts, including employees in other departments as needed.
Manage site quality assurance efforts and take responsibility for site regulatory compliance issues.
Maintain the Quality System by establishing processes 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 ensure achievement of standards and regulations.
Potentially drive broader Quality System improvements across Avalign in collaboration with the VP of Quality & Regulatory and other site Quality Leadership Team members.