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 -- Haemonetics is your employer of choice.

Job Details

The Senior Design Quality Engineer is accountable to manage Penang site change control review board, review all the change impact assessment from the perspective in regulatory, risk management, design control, validation, and verification to ensure all the new change is fully evaluated accordingly. Individual will be a Professional Validation resource to manage validation deliverables on projects and coordinate activities for timely closure of validation activities.

The Senior Design Quality Engineer will interact with the Corp Design Quality team to ensure consistency during assessments of change and impacts for Design change implementation.

SUPPORT NEW PRODUCT TRANSFER, PROCESS AND PRODUCT CHANGE MANAGEMENT BY:

• Represent Quality department as cross-functional team member for product transfer, localization projects, new process change control and new product development projects.

• Manage process change control plan, as a reviewer, approval and implementation of validation and qualification documentation for equipment, product, and processes.

• Analyze data to determine whether processes and systems meet required criteria and specifications. Understand the critical aspects of product, equipment, components, and labeling requirements.

• Lead cross-functional teams in 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 engineering team in creation, review, and approval of engineering study, critical-to-quality & validation protocols

• Manage multiple concurrent validation activities.

• 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. Determine testing acceptability against pre-determined acceptance criteria.

Provide guidance and oversee the maintenance of validated state involving continued process validation, requalification/revalidation of equipment, product, and processes.

• Support development team in creation, review and approval of engineering test protocols and reports in support of design verification, design validation; traceability of user requirements, engineering specifications, and verification & validation testing

Contributes to the overall operations and to the achievement of departmental goals

Ability to work in a team environment and independently as required.

Other duties as assigned

• SUPPORT QUALITY SYSTEM BY:

• Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard

• Initiate, review and approve Non-Conformance reports/Investigations, Change Controls, Deviations, Audit Responses and CAPAs.

• Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections. Participate in internal site audits and audit preparation in support of validation endeavors.

• Lead or participate in problem solving and other work improvement activities

• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. Lead continuous improvement projects and reviews of policies, procedures, instructions, and training

QUALIFICATION & COMPETENCIES

Bachelor's Degree in Science / Engineering

3-5 years or more years working in Medical Device/ pharmaceutical GMP manufacturing facility in a Quality Assurance or related capacity and knowledge of process validation.

Pay Transparency: Residents of certain locations, including Colorado and New York City, may be entitled to additional information about the potential range of compensation and benefits associated with this position. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email .

Conditions of Employment: Haemonetics's requires COVID-19 vaccination for all U.S. employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.