Sr Quality Assurance Manager
Job Description
- Lead and manage QA teams, including training, evaluation, and discipline.
- Ensure compliance with company quality procedures and standards.
- Manage team workload, performance reviews, and resource needs.
- Implement and improve Quality System procedures.
- Resolve significant quality issues and improve cross-functional relationships.
- Mentor direct reports and foster skill development.
- Monitor productivity trends and ensure daily task completion.
- Create and monitor departmental goals and objectives.
- Bachelor's degree in science/engineering with 5+ years quality experience and 2+ years management.
- OR High School Diploma/GED with 7+ years quality experience, quality certification, and 2+ years management.
- Strong written and verbal communication skills.
- Expertise in Quality Management Systems (FDA 21 CFR 820, ISO 13485, MDSAP, ISO 9001).
- Proficiency in MS Office.
- Attention to detail and organizational skills.
- Understanding of Root Cause Analysis.
- Ability to collaborate, mentor, and lead teams effectively.
- Proficiency in leading process improvement initiatives.
- Strategic, proactive, and independent decision-making ability.
- Ability to communicate with top management and identify compliance gaps.
Description
The Senior Quality Manager is responsible for leading teams of QA Technicians, Specialists and/or Supervisors that are focused on a specific Quality discipline in our West Warehouse. Their teams perform work to support the functions of BioFire’s Quality Management System. Senior Quality Managers typically reports to Quality Department leadership.
Senior Quality managers train, evaluate, mentor, guide and discipline the teams they lead. In addition, Senior Quality Managers ensure internal and external customer expectations for accuracy and timeliness are met. Senior Quality Managers Take necessary action within the Quality system to proactively support problem resolution and continuous improvement using quality principles and system tools. Oversee processes, guide initiatives and steer their teams toward the achievement of goals.
Primary job duties
1. Perform all work in compliance with company quality procedures and standards.
2. Timecard review and approval, quarterly and/or annual performance reviews, recommend/approve merit increases, promotions, hires and terminations.
3. Delegate and monitor team workload distribution; consult with senior management regarding resource status and needs
4. Maintain, and report on metrics specific activities of their team.
5. Appraise employee performance.
6. Implementing and improving Quality System procedures
7. Solicit, review and monitor internal customer feedback. Collaborate with internal customers to improve cross-functional relationships.
8. Work with Quality Leadership and other key stakeholders in the prompt resolution of significant quality issues.
9. Interface with other department managers to understand priorities and to communicate status
10. Mentor direct reports; assist in skills/career development, provide motivating work environment and accurate feedback on performance.
11. Seek and obtain additional professional development and skills.
12. Monitor and analyze personnel and process productivity trends
13. Ensure daily tasks and responsibilities are met.
14. Create, implement and monitor departmental Goals and Objectives
Supplemental Data
- Minimal travel may be needed for training opportunities
Minimum Qualifications:
- A Bachelor's Degree in a science or engineering discipline AND at least 5 years of work experience in quality, laboratory, and/or medical device manufacturing roles within a formal quality system setting (e.g., ISO 13485, ISO 9001, FDA cGMP) AND at least 2 years of personnel management experience.
OR
- A High School Diploma/GED AND at least 7 years of work experience in quality, laboratory, and/or medical device manufacturing roles within a formal quality system setting (e.g., ISO 13485, ISO 9001, FDA cGMP) AND a professional Certification related to Quality (CQM, CQE, CQA, SSBB) AND at least 2 years of personnel management experience.
Knowledge, Skills, and Abilities
- Effective written and verbal communication skills
- Knowledge and application of Quality Management System requirements: FDA - 21 CFR 820, ISO 13485, MDSAP, ISO 9001.
- General computer operation, proficiency in internet navigation and proficiency in MS Office tools, including Outlook, Word, PowerPoint, Teams and Excel.
- Attention to detail is fundamental to this position.
- Ability to accurately follow written and verbal instructions.
- Ability to develop and provide clear written and verbal instructions.
- Organization skills as needed to maintain documentation and task schedule.
- Basic math proficiency
- Understanding of Root Cause Analysis principles and methodologies
- Ability to collaborate and interact with peers and employees inside and outside the QA organization.
- Ability to mentor, teambuilding, and coach employees within their organization, including holding crucial conversations, and conflict resolution.
- Ability to lead team and provide feedback, motivation, delegation, influence positive change, evaluate, mentor, guide and discipline the teams they lead, critical thinking, tactical execution of the strategic direction of the team.
- Proficiency with leading process improvement initiatives, facilitating team efforts to establish and monitor customer/supplier relations, supporting strategic quality planning and deployment initiatives, and developing measurement systems to determine organizational improvement.
- Ability to be strategic, proactive, and independent decision maker
- Ability to communicate and coordinate with top level managers and relay important information down to other managers.
- Ability to identify Quality and Regulatory compliance gaps and escalate gaps and possible solutions to quality leadership.
