Manager, Quality Assurance

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.

JOB DUTIES AND 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.

QUALIFICATIONS:

Knowledge, Skills, and Abilities

* 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.

Education and Experience

* 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…