Job Summary
The Incoming QA Inspector is responsible for in-process QA, IQA / MRB, Operator Certification, and Compliance Audits.
Typical Day Includes
IQA – Inspect manufacturing raw materials and components to assure compliance to specifications. Proofread packaging and labeling components. Coordinate raw material chemical, microbiological, and functional testing. Maintain material/component status, including release to inventory, using the material management software. Maintain inspection records.
Preparation and administration of certification tests. Perform non-conforming material review and report results. Maintain area and equipment in a clean, orderly manner at all times. Observe and report on any/all deviations from Good Manufacturing Practices and procedures cited during compliance audits. Ensure familiarity with production processes.
Non-Conforming Event (NCE) – Identify and issue non-conformities associated with equipment, material, or product failing to meet specification. Investigate and identify root cause of non-conformities and provide corrective/preventive actions. Disposition QNs/DCTs as necessary. Administer the MRB process.
Data tracking and trending – Perform basic data entry and elementary mathematical evaluation of data (e.g., average, deviation range). Help in evaluating sampling plans and recommend reduction based on statistical analysis of historic data.
Documentation – Maintain accurate and organized files for inspection records, and/or QA projects. Prepare files for document retention as needed. Maintain updated procedures and specifications.
Miscellaneous – Support validation, process improvement work, and new material introduction. Perform other related duties as assigned by the Manager/Supervisor.
Maintain knowledge of and make needed revisions to applicable SOPs and inspection plans ensuring area personnel are trained on same.
Ensure continual Quality System compliance by adherence to established and evolving regulatory and Alcon QS requirements.
Ensure that the appropriate root‑cause analysis tools are used when leading NCE investigations if applicable.
Education
Minimum: Leaving Cert or equivalent
Preferred: Certificate or Diploma in a Quality related field
Experience
Minimum: 1 year in Quality/Technical or Manufacturing role
Preferred: 2 years experience in Medical Device or Pharmaceutical industry
QA Inspectors are expected to work quickly and efficiently.
They must comply with various regulations/standards and special instructions.
They must be adaptable and flexible and able to move quickly from one job to another.
They must have very good organizational ability and attention to detail.
Benefits
A competitive salary package with fixed salary, bonus, pension, and health insurance.
A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes.
See your career like never before with focused growth and development opportunities.
#J-18808-Ljbffr