Quality Systems Engineer II
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 Excited to grow your career? JOB
Summary:
Responsible for developing and ensuring implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products. 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. Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met. Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including six sigma may be required. Conducts risk analysis as needed. Conducts internal or external audits as assigned to ensure compliance to company quality system requirements. Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use. Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards. Maintains records to ensure compliance to GMP/ISO requirements. MINIMUM REQUIRED EDUCATION AND EXPERINCE:
Bachelor's Degree - Engineering or Life Science discipline or related technical field 3 years' work experience in the medical device industry (FDA 820 CFR 820, ISO 13485:
2016) Disposition of Non-conforming material Monitor and maintain Key Process Inputs (KPIs) Complete customer complaint reports. Statistical process control experience SKILL SETS Computer knowledge and experience with Microsoft Office Preferred Six Sigma certification EEO Policy Statement Conditions of Employment:
Haemonetics' policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. 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, our customers and our communities as we continue to make health and safety our top priority.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Responsible for developing and ensuring implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products. 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. Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met. Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including six sigma may be required. Conducts risk analysis as needed. Conducts internal or external audits as assigned to ensure compliance to company quality system requirements. Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use. Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards. Maintains records to ensure compliance to GMP/ISO requirements. MINIMUM REQUIRED EDUCATION AND EXPERINCE:
Bachelor's Degree - Engineering or Life Science discipline or related technical field 3 years' work experience in the medical device industry (FDA 820 CFR 820, ISO 13485:
2016) Disposition of Non-conforming material Monitor and maintain Key Process Inputs (KPIs) Complete customer complaint reports. Statistical process control experience SKILL SETS Computer knowledge and experience with Microsoft Office Preferred Six Sigma certification EEO Policy Statement Conditions of Employment:
Haemonetics' policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. 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, our customers and our communities as we continue to make health and safety our top priority.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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