Manager, Quality Assurance
Newberg, OR - USA
Job Summary
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-decs reputation for reliable quality dental equipment by ensuring A-decs 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-decs 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-decs market competitiveness.
- Continuously evaluates and improves quality procedures workflows and work instructions to streamline operations enhance team effectiveness and strengthen alignment with A-decs 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 bachelors 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.
Disclaimer
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not to be construed as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to this job. A-dec reserves the right to assign job duties and days and hours of work based on factors such as workload requirements staffing levels and customer demands.
At A-dec we value our people and show it by prioritizing an inclusive culture total well-being and opportunities for learning and career advancement.
A background check and screen for the illegal use of drugs is required.
A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex national origin disability status protected veteran status or any other characteristic protected by addition A-dec will not discriminate against applicants because they have inquired about discussed or disclosed their own pay or the pay of another. *VEVRAA Federal Contractor
A-dec is interested in qualified candidates authorized to work in the United States for US-based positions. We are unable to sponsor or take over sponsorship of employment visas.
Required Experience:
Manager
About Company
Get reliable, ergonomic dental equipment including dental chairs, dental lights, delivery systems, dental cabinets, and more. Learn why dentists consistently vote A-dec best in class.