Quality Assurance Program Manager
4 weeks ago
The Quality Manager is responsible for leading the Quality Program for all CE Services locations and managing the onsite Microbiology Laboratory.
The Quality Manager assumes overall responsibility in ensuring that the division maintains operational and quality systems in a state of compliance to domestic and international standards: IS0 9001, ISO 17025, CFR Part 211, and other applicable standards. This role leads efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality, and quality system compliance.
The Quality Manager also oversees the onsite Microbiology Laboratory. Responsible for technical and scientific oversight and/or direct supervision of laboratory personnel and maintenance of policies, procedures, and quality control practices to assure compliance with cGDP, cGLP, ISO 17025 and other regulatory requirements within the assigned scope of testing.
**1. Lead Quality Program for all CE Services locations (70%)**
- Ensure compliance to the overall Quality Management System and applicable regulatory standards and requirements.
- The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management, and regulatory compliance.
- Lead the organization’s Quality staff in alignment to service operations, support of Lean efforts, and drive quality improvement for products and services.
- Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
- Oversight with non-conformances, OOS investigations, client complaints and deviations.
- Determine supplier qualification risks based upon criticality of component and supplier process capability.
- Work closely with senior management to provide strategic direction and development of the organization’s quality strategies and tactics.
- Provide quality viewpoints and opinions on future product and service development.
- Establish and/or evaluate quality management system and document management software.
- Provide coaching, mentoring, and leadership to the Quality staff.
- Perform other duties as assigned.
**2. Manage Microbiology Laboratory (30%)**
- Supervises laboratory personnel through continual general and direct supervision, interactive staff meetings, time management, and workload distribution.
- Directs and coordinates laboratory activities to ensure that services are provided on schedule within quality and cost objectives.
- Establishes laboratory organization and process plans and delegates responsibilities, authorities, and accountabilities to appropriate staff.
- Ensures adequate training of personnel including documentation of training.
- Designs laboratory workflow processes and efficient testing schedules to ensure timely delivery of test results.
- Oversight with laboratory non-conformances, OOS investigations, client complaints and deviations.
- Ensures documentation, correction, and follow-up of quality and safety events.
- Identify opportunities for improvement and implement subsequent actions to established methods.
- Establish and/or evaluate related work instructions as needed.
- Work collaboratively with Environmental Monitoring Program Manager and other related team members on laboratory initiatives.
- Monitor and analyze monthly volumes, utilization, financial, operational, and quality metrics.
- Oversee maintenance and calibration of laboratory supplies and equipment.
- Provide coaching, mentoring, and leadership to the Microbiology staff.
**Requirements**:
1. Bachelor’s degree in engineering or related scientific field
2. 8-12 years’ experience working in an ISO certified environment required
3. 8-12 years experience of combined Manufacturing/Quality Engineering and/or Quality Systems preferred
4. 8-12 years’ experience with regulated industries preferred
5. Minimum 2 years’ experience in a Quality leadership role
6. Experience working in a Microbiology role preferred
7. ASQ, QSR, or familiarity with QSR/GMP regulations preferred
Pay: $100,000.00 - $125,000.00 per year
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
**Experience**:
- ISO 9001: 8 years (required)
Ability to Commute:
- Needham, MA 02494 (required)
Ability to Relocate:
- Needham, MA 02494: Relocate before starting work (required)
Work Location: In person
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