- Provide quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMP’s of all medical device regulatory agencies.
- Preparation of daily/weekly/monthly metrics for areas of responsibility.
- Monitor and evaluate quality inspection procedures to ensure consistency, compliance and effectiveness, making recommendations for improvement and/or adjustment where needed to Technical Teams / Management for assigned Production Departments (Component, Sub Assembly & Finished Goods). Where appropriate implement approved changes.
- Performing of Internal and supplier quality audits and provision of support for internal and external regulatory audits.
- Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective / preventive actions to improve product quality and output.
- Providing guidance, direction to product line Quality Assurance Technicians and Auditors, Team Leaders / Supervisors on quality aspects of products relating to production departments assigned.
- Provide Quality Performance Information to members of Senior Management.
- Review of document change orders to evaluate each change for quality related issues, initial product release documentation review.
- Completion of retrospective validation, prospective validation or revalidation of products / processes / tooling or methods as necessary.
- Quality representative on relevant Technical Team(s).
- Performs other related duties and tasks as required
Summary of Minimum Qualifications:
- Degree in Quality Engineering or equivalent.
- Minimum of 3 years’ experience in Quality environment, preferably in Healthcare/Medical Device industry.
- Knowledge of quality principles as defined in the regulations and the ability to utilize these methods in a manufacturing environment.
- Demonstrated computer skills preferably spreadsheets, word processing and other applicable software programs.
- Excellent communication and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
- Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively.
- Ability to work as part of a team and meet targets/goals efficiently; take the lead in all quality related issues, set the pace/ standard for the teams that you are part of; ensure that work continues to flow at all times.
- Ability to work under strict time constraints and meet deadlines in a timely manner.
- Ability to read and understand complex manufacturing and production information, including production drawings, work orders, and related manufacturing and quality specifications.
- Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks
- Experience of applying Lean Six Sigma/8-Step problem solving techniques to improve business processes & performance is desirable