Quality Manager

Avalign-Technologies; Akron (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Avalign-Technologies in Akron, OH, seeks a seasoned quality leader to oversee the Quality System, ensuring product quality and regulatory compliance across the site.

The role liaises with government agencies, notified bodies, and customers, directs audits and CAPA programs, and drives continuous improvement to sustain high quality and customer satisfaction. Strong leadership and regulatory knowledge are essential.

Qualifications

• 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.
• Demonstrates ability to design workflows and procedures and translate concepts into clear processes.

Responsibilities

• Lead overall direction, coordination, and evaluation of quality employees; interviewing, hiring, training, assigning, directing, appraising, rewarding, disciplining.
• Act as the site Management Representative for the site quality system.
• Lead regulatory audits (including notified body, unannounced audits, and government inspections) and customer audits; follow up on audit recommendations and nonconformities.
• Manage the CAPA system including root cause investigation and verification of effectiveness.
• Manage the site Management Review process.
• Track and report site Quality Objectives and KPIs.
• Coordinate continuous improvement activities for the Quality System.
• Lead customer communication and problem solving during Manufacturing Transfer for NPIs or complaints.
• Maintain knowledge base of regulations and policies; serve as resource for Quality System.
• Drive broader quality system improvements with VP of Quality & Regulatory and site leadership.
• Ensure high level of internal and external customer service.
• Supervise quality assurance and quality control teams across sustaining and NPI initiatives.
• Mentor and train employees on quality concepts across departments.
• Manage site quality assurance efforts and regulatory compliance.
• Maintain quality system through internal and external inspection of materials and processes.
• Collaborate with cross-functional teams to meet standards and regulations.

Skills

Leadership

Quality mindset

Regulatory awareness

Communication

Problem solving

Education

Bachelor’s degree in engineering or science

Tools

Quality Management System (QMS)

Job description

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.