Sr. Design Quality Engineer
hace 5 días
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
Senior Design Quality Engineer is accountable to support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control. The Senior Design Quality Engineer will work as a member of the cross-functional design team supporting new product development and sustaining engineering change management.
SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT BY:
- Represent Quality department as cross-functional team member for product portfolios, new product development projects,
and product change projects
- Manage project quality plans
- Lead or participate in translation of Voice-of-Customer into development Requirements
- Support development team in 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 development team in creation, review, and approval of engineering development plans & test plans
- Support development team in 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 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 supports 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
- 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
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