About the Role:
Plan, co-ordinate and oversee all QA support activities and initiatives in the value stream. To improve process capabilities and product quality to meet the desired targets.
What you'll do:
- Oversee the product quality from assembly to packaging process and ensure full compliance to the QualitySystem and regulation requirements.
- Champion data-driven decisions to resolve non-conformances, complaint investigation, CAPA, deviation and otherquality matters in a timely manner.
- Interfaces with R&D, unit quality, customer quality engineer to formulate plans and actions to meet product specifications and quality requirements
- Drive quality improvement/automation projects through project planning, scheduling inspection/testing activities, performing analysis and publishing reports.
- Perform test method validation, installation qualification, correlation study for new quality equipment/testmethod.
- Act as a support role for regulatory, external, internal and/or supplier audits and lead the value streammembers to execute the corrective actions for compliance with customer specifications.
- Perform data analysis and trending for product quality performance through monthly and quarterlymanagement review meeting.
- Establish and maintain effective system and procedures to ensure that all manufacturing and engineering documentation are controlled and updated per established regulatory requirements.
- Supervise quality technical specialist and a group of technicians on quality tests and checks.
- Safety & ISO 14001 Environmental accountability: Ensure a safe, healthy and environmentally friendly workplace by observing Company's rules and procedures.
Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials. - Perform any other tasks as assigned.
Job Requirements
- Minimum Degree or Diploma qualification.
- 1-2 years of relevant experience.
- Strong understanding of key elements of Quality Management Systems, including CFR Part 820 and ISO 13485.
- Preferably holds a Six Sigma Green Belt certification or has knowledge of Six Sigma tools.
- Able to multitask effectively and work independently with a high level of initiative.
- Possesses leadership and supervisory skills.
What In It For you
- Competitive fulltime compensation package and benefits
- Paid company holidays (public holidays, rest days, etc.)
- Opportunities for career development and growth
- Convenient company transportation provided
