Assistant Manager/Deputy Manager - Design Quality Assurance - Medical Devices

Qualification & Experience

Engineering or Science related discipline.

A minimum of 3- 5 years' experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.

Familiar with Internal Audit Processes.

Responsibilities

- Identifies and resolves complex exceptions to work assignments.

- Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.

- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.

- Participates in Customer Complaints investigation for areas under their control.

- Continually seeks to drive improvements in product and process quality.

- Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.

- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.

- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.

- Knowledgeable on Risk Management , BSEN 14971 requirements.

- Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.