Responsible for coordinating Quality Assurance activities on the production floor including supervision of QA personnel, and ensuring compliance with all applicable Quality System requirements.
Responsibilities and Essential Functions:
- Coordinate tasks and duties related to quality control within the organization.
- Directly supervise the activities of Quality Assurance personnel engaged in quality inspections over multiple operating shifts to assure that products and processes meet company and regulatory requirements/standards.
- Ensure the results of all inspections are properly documented using good documentation practices in accordance with company policies and procedures.
- Provide support on quality control inspection techniques to functional groups across the organization.
- Ensure proper product identification.
- Responsible for release of all products.
- Responsible for final release of products.
- Designated release officer for the company.
- Ensure proper testing or other verification of incoming products.
- Responsible for ensuring DHRs meet established requirements.
- Ensure that traceable calibration standards are used.
- Ensure nonconforming product is properly segregated and quarantined, products are properly identified with product status in accordance with company procedures.
- Ensure that nonconforming products have a disposition.
- Member of the NCR Response Team.
- Review, investigate, report and assist in the identification of product nonconformances.
- Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
- Responsible for identifying proper training requirements and ensuring personnel training is current, in collaboration with Training Leads.
- Responsible for rework activities.
- Oversee plant policies on health, cleanliness, personnel practices and clothing to ensure integrity of the product.
- Monitor the performance of the quality control staff to ensure alignment with established organizational goals.
- Develop processes to promote cross functional teamwork and the best use of existing competencies.
- Responsible for managing and resolving conflicts involving direct reports.
- Facilitates regular communication and meetings with direct reports.
- Ensuring dissemination of quality related information to the rest of the organization when necessary.
- All other duties as assigned.
- Stop manufacturing
- Disposition of nonconforming product
- Stop product shipments
- Final Release of Ambu A/S products
- Reject to release the product/lot and escalate any problems to NCR/CAPA
- Reject the release of product/lot, if disagreeing with the disposition of an NCR or CAPA
- Discipline and terminate employees in accordance with company policy and involvement from the next level up of leadership
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.
- Bachelor's degree in related field with 2 years of relevant work experience, or minimum 5 years of relevant work experience in highly regulated industry
- Minimum 2 years of supervision experience
- Understanding of cGMP, ISO13485 and CFR part 820 is highly preferred
- Experience working in the medical device field or highly regulated industry
- Must be able to speak, read, write and understand English
- Great verbal and written communication skills