Department: Quality
Reports to: Quality Control Manager
Job Summary:
The Quality Supervisor is responsible for overseeing the quality of High Purity New England (HPNE) products to ensure they meet established standards. This includes supervising and mentoring a team of quality inspectors that are in a cleanroom environment inspecting single use assemblies and maintaining and implementing quality control systems and processes. In this key quality role, the QS will make sure that all products meet HPNE’s high standard of quality.
Supervisory Responsibilities:
- Supervise quality inspectors on first and second shift
Duties/Responsibilities:
Your responsibilities as a Quality Supervisor will include but not limited to:
- Supervise daily direction for Quality Inspectors
- Oversee daily operations in cleanroom environment to ensure quality and customer requirements are met
- Act as the Quality point-of-contact for coordinating and facilitating shipments
- Perform in-process and final inspection of all products for conformance to specifications (inspection procedures and engineering drawings), conducting visual inspection and testing components/assemblies in production, where needed
- Review and approve work instructions and SOPs for production activities
- Perform label inspections (i.e. product labels and box labels)
- Initiate Nonconforming Report for nonconforming material
- Maintain and record quality testing information within a batch record
- Perform thorough batch record review for accuracy and GDocP
- Provide training on quality inspection techniques and sampling plans
- Participate as a Change Control Board (CCB) Member for Quality
- Participate in Drawing Review meetings
- Troubleshoot initiatives to minimize process downtime
- Support cross-functional activities to drive continuous improvement
- Analyze data and identify trends to improve quality
- Perform employee performance reviews and work on the development of the Quality Inspectors
- Support continuous improvement and elimination of waste from processes and methods
- Perform other projects and duties as assigned for the overall benefit of the organization
Required Skills and Abilities
- ISO 9001 experience required
- Experience with Quality Management software: Epicor and ETQ preferred
- Strong experience in GMP
- Proficient in MS Office
- Strong attention to detail
- Must be able to work in a team environment and communicate effectively
- Ability to analyze, identify problems and develop solutions
- Ability to perform basic math calculations
- Ability to read specifications, procedures, and engineering drawings
- Familiarity with use of rulers and calipers
- Batch record documentation and review experience preferred
- Cleanroom experience preferred
Education and Experience:
- Bachelor’s degree in business or related subject preferred
- Minimum 3 years’ experience in related position working with quality systems
- Minimum 1- 2 years’ experience in a supervisory role
Physical Requirements:
- Work does require sitting at a desk, walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 20 lbs.
- Will require to work in a cleanroom environment with appropriate attire (gown, mask, hair net etc….) and standing for extended periods of time.