Job Summary
Responsible for supporting the quality control staff in the receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards. Reporting on the performance of the assigned quality areas. Management of QA/QC staff, GMP and ISO compliance.
Job Details/Responsibilities
- Manages Production Quality staff overseeing Receiving Inspection, Cleanroom, and Final Release areas, including all inspectors, analysts, and technicians that report into the supervisors of those areas.
- Identifies, Reports and Monitors Nonconforming events for the Receiving, Cleanroom, Final Packaging and Release areas.
- Performs product failure investigations and implements corrective and preventive actions to prevent reoccurrence.
- Interacts with cross-functional teams to resolve quality issues.
- Quality Control, product release authorizations, and quarantine of all suspect or discrepant product.
- Develops Quality Instructions and Quality Standards.
- Support in the development, validation, and implementation of Test Methods.
- Reviews and approves engineering changes to support product life cycle.
- Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaints investigations, Nonconforming events, etc.
- Supports the Corrective and Preventive Action (CAPA) System.
- Identifies and evaluates fundamental compliance issues for major functional areas through assessment of quality system compliance.
- Establishes Quality Assurance objectives and assignments, and delegates assignments to subordinates.
- Involved in executing company policies.
- Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
- Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)
- Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT)
Job Responsibilities (continued)
Working Conditions/Physical Requirements
Knowledge, Skills and Abilities (KSA)
- Works with all levels within the company.
- Strong communication skills (written and oral)
- Ability to organize and conduct multiple, parallel tasks.
- Ability to seek and utilize varied resources.
- Ability to influence others.
- Understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485.
- Understanding of required standards / regulations impacting Medical Devices.
- Leadership ability and organizational skills.
- Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
Qualifications/ Background Experiences
- A bachelor’s degree or equivalent experience in Engineering, Quality Engineering or Sciences.
- 8+ years of related experience in a regulated environment in Quality Assurance and or Manufacturing/ Engineering environment.
- Must have experience handling nonconforming events.
- Packaging/Labelling process experience is a plus.
- SAP knowledge is a plus.
