Quality Assurance Engineer

2 days ago

Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

**PURPOSE OF JOB**
- Assures product quality requirements are fulfilled in accordance with the Plant’s quality system and in compliance with corporate policies, customer, regulatory and statutory requirements.
- Provides quality engineering expertise in Catheter & Transducer production line (pulmonary Artery and Central Venous Catheter and Accessories & Transducers) and other related manufacturing operations and key Plant initiatives.
- Drives opportunities for continual improvement and drives QE section initiatives in respective function so as to support departmental goals in alignment to Plant’s vision, objectives and shared values.
- Perform effective failure analysis and provide investigation report to customer in a timely manner.
- Manage the quality control inspection and ensure good quality of product release.
- Support Internal Audit program to ensure Plant’s Quality System complies with 21 CFR Part 820 - Quality Systems Regulation, ISO13485 / MDSAP and any other applicable standards & government regulations including effectiveness review of system for continual improvement

**JOB FUNCTION**
- Provide technical support for the department and cross functional teams in achieving QE section initiatives and plant objectives.
- Manages, leads, and develops QC inspectors.
- Leads and/or works with cross functional teams/departments to ensure product quality and quality system requirements are fulfilled including effectiveness review of system for continual improvement
- Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; displays willingness to make decisions; exhibits sound and accurate judgment in decision making.
- Conduct internal audits to ensure area of audit complies with Plant’s Quality Management System.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.

**JOB SPECIFICATIONS**

POSITION REQUIREMENTS

**_Education _**_: _
- Education and/or experience equivalent to a bachelor’s degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential

**_Relevant Experience _**_: _
- At least 2 - 3 years of relevant work experience in a manufacturing environment, two of which should be in quality related areas
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Regulations, ISO 13485 / MDSAP Quality System Standard and ISO 14971 Risk Management
- PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.

**_Others _**_: _
- Certified Six-Sigma Black/Green Belt and Validation practitioner is a plus
- Certified Quality Engineer and Certified Lead Assessor will be an advantage
- Familiarity with Lean Manufacturing and Project Management
- Knowledge in plastic / polymer technology
- Ability to contribute in a team environment, action oriented, strong drive for results, and good influencing skills.
- Ability to contribute in a team environment, action oriented, strong drive for results, and good influencing skills.

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