Manager, Quality Assurance

A-dec Inc.•Newberg, OR

About The Position

At A-dec, we do more than create the highest quality products and services for the dental industry; we strive to deliver a superior employment experience for each of our team members. With an environment that encourages and assists each person in developing to their highest potential, a career at A-dec is incredibly rewarding. Overview The Quality Assurance (QA) Manager is responsible for protecting A-dec’s reputation for reliable, quality dental equipment by ensuring A-dec’s Quality Management System meets or exceeds regulatory, company, and customer requirements. They are responsible for leading a team of QA Specialists and Engineers to deliver effective quality systems, processes, and insights that drive product and process improvement while balancing quality with productivity.

Requirements

Knowledge of international standards and regulations (e.g., ISO 13485, MDSAP, FDA 21 CFR 820, CMDR SOR/98-282, Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745) and quality concepts (e.g. statistical analysis, root cause analysis, and quality metrics/analytics).
Must have excellent interpersonal skills; written and verbal communication for dealing with internal and external customers (e.g. A-dec department leaders, regulatory agencies), along with strong attention to detail and a high level of customer focus.
Ability to organize, coach, and lead cross-functional teams in addition to having strong organizational and time management skills; exercise good judgement using risk-based decision making, and use resources effectively.
Requires strong analytical skills, quality system expertise, and the ability to manage multiple priorities in a fast-paced manufacturing environment.
Proficient with all Microsoft Office Suite applications and experience in project and database management.
Requires a bachelor’s degree in business or engineering or equivalent and a minimum of ten years of experience in Quality or related field with 3-5 years in a leadership experience.
Leadership may include people leadership, technical leadership, and/or project leadership with demonstrated ability to coach and mentor others, support team member development, and influence outcomes through effective leadership and collaboration.
Generally requires American Society of Quality (ASQ) certification.

Responsibilities

Provides team leadership that facilitates efficient and effective support of enterprise quality management for product and process quality.
Provides technical guidance and coaching to team through communicating job expectations, planning, monitoring, and appraising job results to ensure department goals are met and promoting employee personal growth and development.
Action-oriented leader with strong execution skills, deeply embedded in the daily function and technical execution of quality duties.
Responsible for managing, supporting, overseeing, and improving A-dec’s Quality Management System (QMS).
Actively participates in internal and external (ISO, FDA, etc.) audits that assess the effectiveness of the QMS.
Leads departmental and enterprise-level quality initiatives, translating strategic direction into scalable, actionable systems, tools, and processes.
Leads process creation and improvements; drives process adoption; operationalizes systems and processes throughout organization; partners with a broad network of A-dec Engineers and Managers.
Develops and maintains the appropriate metrics to track corporate quality; performs quality data analytics; partners with cross-functional subject matter experts to extract insights, uncover trends, inform decisions, and drive improvements.
Serves as an organization-wide technical expert in advanced quality disciplines by applying an extensive and diversified knowledge of advanced quality techniques, procedures, and criteria.
Drives quality capability development across A-dec through training and using established processes such as root cause analysis and corrective and preventive action.
Fosters the creation and application of improved quality methods, systems, and solutions to elevate product quality and strengthen A-dec’s market competitiveness.
Continuously evaluates and improves quality procedures, workflows, and work instructions to streamline operations, enhance team effectiveness, and strengthen alignment with A-dec’s Quality Management System.