Principal Quality 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

The Principal Quality Engineer plans conducts and directs engineering projects or studies including complete projects requiring advanced knowledge in a specialized field. Applies a broad and diverse knowledge of engineering principles and practices within assigned areas. The Principal Quality Engineer will use quality engineering tools and practices for effective and efficient development transfer and maintenance of products/processes throughout the product life cycle. Utilizes quality engineering principles and problem solving and investigation skills to improve and maintain products/processes that are aligned with the overall quality and business vision. Utilizes appropriate risk management to prevent unanticipated failure modes and improve process capability. ESSENTIAL DUTIES Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Enter Responsibilities/Essential Duties Support the development of quality engineering and quality compliance with appropriate skills for new product introduction and product life cycle management. Review and approve engineering change controls. Review/analyze whether current products and processes (including actions or decisions taken) comply with standards such as OSRs ISO etc. including providing support during internal and external audits. Participate in preparation activities for/or interactions with regulatory agencies (FDA MDSAP etc.). Respond to observations from internal or external audits related to the quality engineering function. Establish and maintain appropriate required documentation of quality assurance activities and/or quality systems. Conduct or support investigations documentation review and approval of nonconformities (NCEs) and corrective and preventive actions (CAPAs). Escalate quality issues as applicable. Support the review and maintenance of PFMEAs Quality Control Plans Process Instructions and additional manufacturing documents. Responsible for communicating business-related issues or opportunities to the next management level. Lead internal and external audits (Corporate FDA Notified Body Customers) of the quality systems and other compliance activities. SUPERVISORY RESPONSIBILITIES Carries out supervisory responsibilities in accordance with the organizations 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. None QUALIFICATIONS EDUCATION Education Level Education Details Required/Preferred Bachelors Degree Industrial engineering or equivalent. Required EXPERIENCE Experience Level Experience Details Required/Preferred 5 years Medical devices or Pharmaceutical industry working experience. Required SKILLS Skill Sets Other Skills Proficiency Strong verbal communication and listening skills. Demonstrated written communication skills. Effective negotiation skills. Effective interpersonal skills. Other Solid knowledge of quality systems. Other Direct working experience with FDA or other regulatory agencies. Other Working experience with Class II or III medical devices preferred. TRAINING/CERTIFICATIONS List Each Training/Certification Required/Preferred ISO 13485 Training. Preferred Six Sigma certification. Required

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