- Experience
- 3–5 yrs
- Salary
- —
- Openings
- 1
- Posted
- 2 days ago
Where you'll work
Job description
About the Role
This is an exciting contract opportunity to join a leading medical device client. Please note that visa sponsorship is not provided for this position; candidates must possess a valid visa.
Responsibilities
- Oversee the entire Event Investigation process, ensuring CAPA system compliance and timely resolution of all customer investigations.
- Provide support for both ongoing and new projects related to manufacturing operations.
- Participate in and support all product and process audits in accordance with established procedures.
- Employ suitable problem-solving methodologies to provide sound and consistent recommendations in Engineering and Quality Assurance.
- Address and resolve complex exceptions encountered during work assignments.
- Analyze test results and other process-related findings, summarizing data, drawing conclusions, and making informed decisions.
- Exercise independent authority and responsibility for decisions concerning product quality, including the disposition of non-conforming products.
- Ensure alignment and compliance with Corporate SOPs, maintaining up-to-date site documents and collaborating with the Regulatory Compliance Officer on key tasks.
- Demonstrate flexibility to support various Quality Department functions, including Customer Quality Engineering, Supplier Quality Engineering, and QMS activities such as the Internal Audit program, Performance Excellence, Management Review, Business Continuity Management, and Key Quality Projects, working alongside Lean Six Sigma and Operations Excellence leads.
Requirements
- Possess a Level 8 Degree (240 Credits) or an equivalent qualification in a STEM discipline.
- Accumulate a minimum of 3-5 years of pertinent professional experience, preferably within the Medical Device sector or a similarly regulated industry.
- Prior experience providing line support in Operations/Manufacturing is considered an advantage.
Additional Information
A valid visa is required for this contract role, as sponsorship is not offered.