Quality Assurance Director

About the role

Bio-Works is looking to strengthen its Quality Assurance team with a director-level role tasked with defining and promoting a quality mindset across the entire company. The QA Director is responsible for managing all QA functions, working with cross-departmental leadership to deliver high-quality products on schedule.

Responsibilities

- Assures quality products and processes by establishing and enforcing quality standards and testing materials and products per ISO 9001:2015.
- Develop the QA function according to Bio-Works' strategic plan
- Act independently of Bio-Works management in handling QMS resources and activities
- Create product quality documentation system by writing and updating quality assurance procedures.
- Maintain product quality by enforcing quality assurance policies and procedures and government requirements.
- Collaborate with other members of management to develop new product and engineering designs and manufacturing and training methods.
- Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Complete quality assurance operational requirements by scheduling and assigning employees and following up on work results.
- Develop a quality assurance staff by recruiting, selecting, orienting, and training employees.
- Manage quality assurance staff job results by coaching, counseling, and disciplining employees.
- Ensure quality by planning, monitoring, and appraising job results.
- Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
- Achieve financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
- Contribute to team effort by accomplishing related results as needed.


Requirements (skills)

- BA or BS in appropriate discipline
- Five to 10 years’ experience as QA manager or director in ISO 9001:2015 company
- Working knowledge of quality system requirements
- Experience with MS Word, Excel, Project Management and Analytics software
- Strong communication, negotiation, and management skills.
- Business fluency in English and Swedish are required.
- Experience with LEAN / KANBAN / Six Sigma is a plus.


Requirements (personality)

- Strong leadership skills both in terms of self-leadership and leading teams
- A proactive risk-based attitude focused on identifying problems and solutions.
- A collaborative mindset
- A precise and analytic mindset to identify and focus on issues and risks.




Do you have a question?

For any questions, you are warmly welcomed to contact Jonathan Royce at jonathan.royce@bio-works.com.