Senior Design Quality Engineer

Haemonetics • Boston, MA

1d

About The Position

The Senior Design Quality Engineer is accountable for supporting 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.

Requirements

• Support new product development & product change management
• Support quality system

Responsibilities

• Represent Quality department as a cross-functional team member for product portfolios, new product development projects, 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
• 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

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• employee stock purchase plan
• flexible time off for salaried employees
• accrual of three to five weeks’ vacation annually (based on tenure) for hourly employees
• accrual of up to 64 hours (annually) of paid sick time
• paid and/or floating holidays
• parental leave
• short- and long-term disability insurance
• tuition reimbursement
• health and welfare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed