Quality Assurance Technician 9 month FTC
A number of vacancies currently exist within the Quality Department on evening and weekend shift:
Summary of Duties/Responsibilities:
- Quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMP’s of all medical device regulatory agencies (e.g. FDA, ISO and MDD).
- Quality support for areas of responsibility.
- Review and assessment of all quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas as appropriate.
- Preparation of daily/weekly/monthly metrics for areas of responsibility.
- Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective actions to improve product quality and output.
- Participation in retrospective validation, prospective validation or revalidation of products/processes/tooling or methods as necessary.
- Providing guidance, direction to product line Quality Assurance Auditors, Supervisors, Team Leads and Production Operators on quality aspects of products.
- Conduct product release testing, involving sample collection, testing, documentation and communication of results; perform Work Order ‘Close outs’ — Finished Goods Sterile Product.
- Preparation of quality reports for quality meetings and reviews.
- Supporting internal and external regulatory audits.
Quality System support to production teams / quality engineers as required.
- Initiation of initial release / document changes ECN/ECO for procedures relevant to all tasks.
- Other related quality tasks as required.
Summary of Qualification/Experience:
- Diploma in Engineering / Science or equivalent qualification; Diploma in Quality although not required is desirable.
- Minimum of 1 years’ experience in a quality environment, preferably in Healthcare/Medical Device industry.
- Knowledge of basic quality principles and ability to utilize these methods in a manufacturing environment.
- Strong interpersonal and organisational skills and the ability to work effectively as a team member.
- Self-directed/starter: Ability to work under strict time constraints; meet deadlines in a timely manner with minimal guidance.
- PC skills with a good working knowledge of Word, Excel etc. Oracle knowledge an advantage.
Merit Medical is an equal opportunity employer
To apply for this job please visit recruiting.adp.com.