POSITION OVERVIEW:
The Quality Assurance Manager is responsible for the planning and execution of activities related to the maintenance and development of the Quality Management System (QMS). The Quality Assurance Manager ensures that internal policies and procedures are followed, enabling BioTouch to provide consistent high-quality products that meet customer requirements.
RESPONSIBILITIES:
1. Manage, maintain, and enhance the QMS, including CAR, NCMR, DCR, Supplier records, and Complaints.
2. Maintain quality metrics for Management review and monthly reviews.
3. Support the development and training of new starters at BioTouch, ensuring established quality standards are maintained.
4. Maintain compliance with ISO 13485:2016 requirements.
5. Ensure internal audits are completed on schedule, conduct internal audits, and participate in the internal auditing team.
6. Evaluate internal audit findings and implement an effective CAR system.
7. Periodically review and edit current quality assurance procedures and develop new QA-related procedures and work instructions where needs are identified.
8. Lead, coach, and develop all personnel within the Quality team to continually improve quality performance and manufacturing efficiency.
9. Proactively evaluate existing and emerging quality requirements and direct implementation of activities to assure compliance with ISO.
ABILITIES REQUIRED:
1. Degree in business, science, or engineering with a minimum of 3 years prior experience in a leadership Quality Assurance role for a regulated industry (Medical Device/Pharmaceutical), or a minimum of 5 years experience in Quality Assurance in the Medical Device/Pharmaceutical industry.
2. Strong interpersonal and professional skills in verbal and written communications, customer focus, service to internal and external customers, training, influencing, and team building.
3. Proficiency in Microsoft Office applications such as Word, Excel, and PowerPoint.
4. Experience with ISO 13485:2016.
5. Experience in quality system audits.
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