Company Description
**Job Description**:
**Production Quality Engineer**
Job Description Summary
The incumbent is responsible and accountable for establishing and coordinating Quality Control Plan activities for materials, products, equipment, processes and software.
Lead in investigating manufacturing product quality issues, non-conformances, audit observations and customer complaints. Develop problem-solving methodologies from production processes based on engineering and statistical principles.
You will lead the Risk Analysis/ PFMEA to identify needs for validation of manufacturing equipment/ process / software and support systems to meet product requirements, regulations, quality and company policies.
Job Responsibilities
- Responsible for developing, implementing and maintaining the Risk Analysis / FMEA and Validation Master Plan for the Plant & supporting Quality Engineering activities including process monitoring, continuous improvements, metric reporting, data analysis, change control & control plans
- Coordinates, supervises groups of Quality Assurance personnel on an ongoing validation activity for any projects in production
- Responsible for providing support, training and assistance to production and quality personnels
- Continuously evaluate information related to the overall performance of manufacturing process / equipment / software and any relevant support systems in addition to field complaints to activate re-validation activities when required
- Create, revise or update validation procedures and policies as required. Prepare Change Notification documentation as required for procedures or processes as a result of validation requirements
- Participate in Management Reviews and Executive Steering Committee to report on Quality status
- Perform internal QA Audits. Assist/support in external customer and regulatory audits as required
- Leads cross functional teams for quality initiatives project for continuous improvements as per Quality tools such as Design of Experiments, Statistical/ Data Analysis, and MSA / Correlation
Job Requirements
- Bachelor's Degree or equivalent in related Engineering field
- Minimum 5 years relevant working experience in an assembly operations/engineering environment.
- Good knowledge of PFMEA, process/software validation and various statistical control methods
- Strong background in QMS 9001
- Strong analytical and problem-solving skills
- Knowledgeable root cause investigation tools such as 5 Whys, fish bone diagram and Is/Is Not analysis
- Working knowledge of statistical tools - Cpk, SPC, MSA
- Substantial understanding and knowledge of calibration, measurement techniques and metrological concepts.
- Computer literacy in MS Office modules and Google Workspace deseable
- Must have good language proficiency in English
- Added advantage in process analysis, problem solving skills, and improvement using process flow and/ or Lean Manufacturing method.
Supervision / Reporting Relationships
- Supervision, coordinates groups of quality personnels, contributors, engineers and/or technicians.
**Qualifications**:
Accountability
- Lead in investigating manufacturing product quality and compliance issues such as non-conformances, audit observations, customer complaints for production processes based on engineering and statistical principles and problem-solving methodologies.
- Be a Member of the Material Review Board. Review, evaluate and determine the disposition of non-conforming material
- Partner with engineering and supplier quality teams (cross functional teams) on root cause investigations on customer complaints and assures documentation content is valid.
- Lead RCA investigation and drive quality improvement
- Lead, review and analyze key Quality Indicators and collaborate with manufacturing and supplier quality departments to proactively resolve non-conformances and operational issues.
- Perform data analysis (pareto and trending) for compliant and non-conformances to identify systemic improvements.
- Provide regular progress reports and quality metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement.
- Supervise employees and quality activities, pertaining to the production of products and/or manufacturing processes in - and with quality/statistical/technical knowledge of - multiple production areas, including calibration
- Drive and influence Quality and Productivity improvement by participating in lean and continuous improvement initiatives and projects
- To communicate and be engaged with External customers
Personal trait profile
- Team player with good communication and interpersonal skills
- Highly motivated, detail oriented, critical thinking skills, proficient in oral and written communication in English
- Self-starter and resourceful.
- Possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, as well as mediatin
