Job ID :
Malaysia - Cheng
- Provide Quality input to Operations investigations, deviations, change controls, validation protocols, validation reports, SOPs, and in-process controls.
- Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
- Assist Operations in troubleshooting process issues and facilitate inter-department team workshops in the resolution of process issues and quality problems.
- Work closely with Operations, R & D, Purchasing and Engineering to improve quality while reducing material scrap and costs.
- Drive quality management focus on productivity improvements throughout operations.
- Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.
- Serve as Quality Representative for all quality-related corrective/preventive actions within Operations.
- Assure that Operation's standards comply with division and departmental policies, national and international codes, and applicable safety requirements.
- Analyse trends and collaborate with Operations to investigate trends, conduct root cause analysis and implement corrective actions for processes and products.
- Participate and support internal / external audit program.
- Bachelor’s degree required in science discipline or related field
- A solid level of quality assurance experience in a medical device or pharmaceutical manufacturing environment.
- Strong background in process control and statistical techniques.
- Medical device, GMP, EU Regulation or ISO 13485 background.
- Demonstrated working knowledge of compliance, quality and scientific principles.
- Strong oral and written communication skills.
- Must be a self-starter who can take general concepts and direction and produce desirable results.
- Ability to prioritize multiple tasks functions effectively in a global, multi-site organization.
- Demonstrated ability to work effectively as a member of a cross-functional team.
- Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma/PPI.
- Strong working knowledge of various computer software, such as SAP, as well as Microsoft Word, Excel and PowerPoint.
- Experience with lean manufacturing practices.
- Knowledge of qualification / validation (process, sterilization, cleaning, software) requirements.
- Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
- May be required to perform other related duties as required and/or assigned.
Essential Hiring Criteria:
- Excellent oral and written communication skills.
- Strong leadership skills with the ability to challenge, influence, and build consensus.
- Ability to work both independently and as a team member.
- Strong quality background and problem analysis and decision-making skills.