Quality Engineer

Medical devices, Pharmaceuticals, Health, Social work
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Randstad Multilingual Recruitment Banen
Job Ref:

1. Objective of this job
Ensure that development project targets on product quality are achieved and that defined Product Quality processes are implemented.
Provide Leadership in steering all quality related activities in a development project.

2. Responsibility of the job holder
Responsible for integral Product Quality and Product Quality processes in a project as defined in Function Development and Integral Product Development (PDLM).
Assist and coach project team on the Project Quality plan.

3. Key Performance Indicators for the job holder
Implementing the defined Product Quality Processes, measured by DFSS tracker score on a monthly base.
Providing enabling indicators for product quality during the project, (Cpk values for CTQ s, MTBF on Reliability and FOR on product process capability), leading to targeted Rating Reviews improvement and CONQ reduction.
Achieving the target product quality performance at the end user, i.e. R R and Field Call Rate (FCR).

4. Authority of the job holder
Report to Development Quality Manager on product project quality items.
Partner with Project Leader on project quality aspects.
Escalate product quality issues, when needed, to stakeholders
Mandatory advice on pass hold during the milestone meetings based on above KPI s.

5. Tasks of the job holder
Provide leadership and steer all product quality related activities in Product Development with special attention for
Requirement development.
Robust Reliable Design, driving capability and reliability requirements.
Risk Problem and margin Management drive and review FMEA s, PMI s, Problem log s.
Ensure proper definition and execution of the product quality test plan in a project, covering all chapters of the Quality plan
Design Evaluation Verification Validation Testing.
Product Process Maturity Testing, Early Market Feedback.

Ongoing Reliability Testing.
Safety risk assessments, proper initial approbation and country approbation.
Communicate regularly on the quality status, monitor FCR throughout the project execution, Capture learning s from earlier projects (both on the development process and on technical issues, FCR improvements) and initiate improvements in the new current project.
Support SQA in above tasks for ODM based product development projects.
Provide advice based on the Quality information available during the milestone meeting and mandatory advice the stakeholders if the criteria are not met to pass the project Milestone.
Provide an interface between the project team members (including Supplier Quality Leader, Industrial Quality Leader and Consumer Care representative) and the Project Leader, on product quality aspects.
Identify quality training and support needs within the project team and organize improvements.

6. Competencies of the job holder
Basic requirements
Technical Academic University degree or Equivalent.
At least 5 years experience in product development.
Experienced in Quality Assurance methods and tools (DFSS, Greenbelt level)
Relevant technologies to product category concerned.
Product Quality Management
Functional Competencies
Influence environment for project success
Team player, build successful teams
Lead change in the organization
Plans and executes projects for business results
Good communication and presentation skills

7. Tools and methods used by the job holder
Project Management Methods and Tools
Technology and Function Creation methodology (Advanced Development process )
Integrated Product Development (PDLM process)
DFFS tracker
Product Quality Methods and Tools
Requirement Development methods.
FCR target setting, prediction Follow up CREX method
Basic statistics Hypothesis testing GR R, Capability analysis. Cpk s Z scores
Critical To Quality (CTQ) flow down and Capability flow up
Risk analysis several types Failure Mode Effect Analysis, can act as FMEA Coach.
Transfer function principles Design Of Experiments, Sample Sizes, Confidence Levels
Robust Design Life time testing, Reliability Testing, basic Weibull statistics MTBF, FCR prediction
HALT Highly Accelerated Life Testing, test to Failure
Supplier Quality methods, APQP
Compliance, safety and regulatory regulations
Sustainability requirements,
Problem solving methodologies.

8. Glossary
ASD Architecture Standard Design
AQP Advance Quality Plan
CoNQ Cost of Non Quality
Cp Capability Process
Cpk Capability Process Index
CROT Commercial Release On Time
CROV Commercial Release On Volume
CTQ Critical To Quality parameter
DOE Design Of Experiments
DFSS Design For Six Sigma
DR Design Release
DQ Development Quality
FCR Field Call Rate
FMEA Failure Mode and Effect Analysis
FOR Fall Off Rate
FRR Fast Return Rate
GR R Repeatability reproducibility
HALT Highly Accelerated Life Testing
IPD Integral Product Development
IQMS Integrated Quality Management System
ISO International Standard Organization
JAR Joined Application Release
MTBF Mean Time Between Failures
NPS Net Promotor Score
PBE Philips Business Excellence
PDLM Product Development Launch and Maintenance
PMI Process Maturity Index
PFQ Predicted Field Quality
PQM Product Quality Management
SQA Supplier Quality Assurance
SET Simplicity Experience Tracking
VOC tree Voice of Customer tree
VPH Value Proposition House
Z Z value ( capability)

Closing Date:
Contact Details:
Randstad Multilingual Recruitment Banen
Contact: N/A

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