Job 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 \xe2\x80\x94 Haemonetics is your employer of choice.

Job Details

Essential Duties

• 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\xe2\x80\x99s (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

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

• 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

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

\xe2\x98\x91 Exposure to moving mechanical parts, vibration and/or moderate noise levels.

\xe2\x98\x91 Exposure to hazardous chemicals or other materials.

\xe2\x98\x91 Exposure to blood.

Travel Expectations: Minimal 0-10%

Haemonetics