- SUPPORT PRODUCT CHANGE MANAGEMENT BY:
- Represent Quality department as a cross-functional team member for product portfolios, and product change projects
- Manage project quality plans
- Lead or participate in the translation of Voice-of-Customer into development Requirements
- Support the development team in the creation, review, and approval of engineering Requirements & Specifications in accordance with standard operating procedures
- Lead cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to Hazard Analysis, Risk Management Plan & Report, FMEA's (Use, Design & Process), Fault Tree Analysis (FTA)
- Lead or support the development team in the creation, review, and approval of engineering development plans & test plans
- Support the development team in the creation, review, and approval of engineering test protocols and reports in support of design verification, design validation, and process validation
- Lead the development team in creation, review, and approval of critical-to-quality specifications
- Support development team in the creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing
- Lead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods
- Define statistical testing methods and sampling in support of verification and validation testing
- Ability to support any Product Line Portfolios and actively support 1 or more Product Line Portfolios
- Ensure accuracy and completeness of the Design History File and the Device Master Record
- Compile, review, and analyze failure data to provide feedback to the development team
- Mentor, develop, coach, and/or supervise less experienced quality engineers
- SUPPORT QUALITY SYSTEM BY:
- Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard operating procedures, and instructions
- Supporting and administering quality system elements including but not limited to: Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling, etc.
- Lead continuous improvement projects and reviews of policies, procedures, instructions, and training
- Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections
- Lead or participate in problem solving and other work improvement activities
- Effective interpersonal skills
- Articulate and responsive to colleagues
- Excellent collaboration and team building skills
- Effective negotiation skills
- Effective conflict management skills
- Understanding of Medical Device Regulations
- Project Management Skills
- Technical Writing (Requirements / Specifications)
- Voice-of-Customer Development & Analysis
- Failure Modes & Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Measurement Systems
- Applied Statistics
- Continuous Improvement
- Reliability Testing
- Ability to Train / Mentor others
- Product Knowledge: Blood Collection, Apheresis, Hemostasis Management, Software
- Business Acumen: Markets, Finance
Senior Design Quality Engineer - Simpang Ampat, Malaysia - Haemonetics
Description
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Job Details
Essential Duties
Supervisory Responsibilities : None
Qualifications
Education
Bachelor's Degree in Electrical, Biomedical, Mechanical, other equivalent technical engineering discipline (Advanced degree, Masters or PhD, substitute 2 years experience below) - Required
Experience
5 years: In a medical device or equivalent regulated environment - Required
5 years: Design Quality Engineering or equivalent design experience - Required
Skills
Training/Certifications
Familiar with Microsoft Word, Microsoft Project, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Adobe Acrobat - Required
Professional certification as one or more of the following:
Certified Quality Engineer
Certified Reliability Engineer
Certified Six Sigma Black Belt
Physical Demands
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Exposure to blood.
Travel Expectations : Minimal 0-10%
EEO Policy Statement