Quality Assurance Manager

2 weeks ago

Singapore BIOBOT SURGICAL PTE. LTD. Full time

**_Competency Requirements _**
- Diploma/ B. Eng degree in Electrical, Electronic Engineering
- Knowledge/Experience in Product development cycle, product qualification testing, including EVT and DVT, as well as PRT.
- Experience in medical device industry for more than 2 years; experience in QMS with working knowledge of ISO13485, MDD, FDA QSR
- Demonstrated knowledge of **FMEA, DOE, DFSS **, and problem-solving methodologies.
- Knowledge of common programming languages.
- Basic understanding of manufacturing processes.
- Possesses good communication and analytical skills.
- Ability to work cross-functionally with minimum supervision.
- Ability to write quality procedures and technical documentation.
- Knowledge in project management.
- Prior knowledge of customer complaints handling would be preferred

**_Responsibilities _**

1. **Design Quality and Reliability Engineering**
- Develop and execute comprehensive product qualification plans to validate specification data.
- Work closely with design engineers in DFMEA and DoE to ensure all specifications and quality goals are in place.
- Risk assessment of Product Specification and Propose Quality Assurance Test Plan
- Work closely with R&D, production plants, quality department, field service and other internal entities to highlight, support and resolve all design / process related problems in a timely manner that constantly meet customers’ product specifications and quality requirements.
- Identify quality gaps, prepare and present quality and project reports, and make recommendations to address quality issues and to improve design margins and product robustness.
- Work closely with the design team on a reliability program that includes, prediction modeling (MTBF/MCBF calculations), accelerated and life demonstration.
- Develop component level and system integration test requirements, methodologies and processes.
- Develop Manufacturing Quality plan to determine In-process/ Out-going test coverage to ensure product meet specification
- Collaborate and coordinate with Testing Agency for Product Testing

**2. **Quality Assurance (QA)**
- Perform activities related to the documentation of Quality Management System (QMS) and ensure relevant processes and activities are in compliance with ISO13485, MDD 93/42/EEC, IVDD/98/79/EC, FDA21 CFR820, and other statutory or regulatory requirements in the capacity of Management Representation (MR);
- Responsible for document control;
- Prepare and co-ordinate both internal / external (including supplier) audits;
- Provide QMS support to cross-functional teams, and ensure execution and effectiveness of key quality system processes;
- Ensure design changes are tracked and process change requests in a timely manner;
- Manage non-conformities (product and process) and track progress of resulting corrective action and preventive actions

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