Senior Quality Systems Engineer

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

Job Summary:

The Senior Quality Engineer is responsible for developing and coordinating implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products in compliance with QMS.

Primary Responsibilities:

• Conducts internal or external audits as assigned to ensure compliance to company quality systems requirements.

• Develops, reviews and challenges existing quality driven test systems and procedure to assure products meet intended use.

• Leads product improvement projects and consults on supplier changes to ensure qualifications are met.

• Lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. 

• Maintains records to ensure compliance to GMP/ISO requirements.

• May manage and lead CAPA program, implementing global CAPA policies.

• Other quality management projects and duties as assigned.

• Comply with all ISO 14001 requirements.

• Comply with internal environmental management system requirements, as applicable.

• This position may involve exposure to blood, harsh chemicals, or other materials. Employees are expected to adhere to site safety policies and use appropriate personal protective equipment (PPE). Training and PPE will be provided as will access to appropriate vaccinations by Haemonetics.

• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Physical Demand

• Sit; use hands to finger, handle, or feel objects, tools, or controls. 

• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

• Lifting/moving up to 10 pounds.

• Exposure to moving mechanical parts, vibration and/or moderate noise levels. 

• Exposure to hazardous chemicals or other materials.

Qualifications:

• Bachelor's Degree - Engineering or Life Science discipline or related technical field

• 5+ years of work experience in a related function, required.

• 2+ years of experience in the medical device industry, required.

• Professional experience with Statistical Process Control, required. Minitab, strongly preferred.

• Computer knowledge and experience with Microsoft Office and document management systems (for example, Agile), required.

Skills:

• Demonstrated written communication skills

• Strong verbal communication and listening skills

• Highly thorough and dependable

• Leadership

• Problem solving

• Fluent in English. Able to write clearly and concisely in daily activities

• Independent in task execution. Meticulous, focus and attentive to details and accuracy in all aspect of the job

• Positive attitude, able to influence and lead different groups of employee, motivate and guide people towards organizational success

• Analytical minded, resourceful, statistical based decision, data driven direction, use quality tools and methodology in delivering results

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