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
Ensures that processes needed for the quality management system of Haemonetics are established, implemented and maintained. Responsible to ensure the completeness of documentation package submitted to Agile Product Lifecycle Management and maintain the integrity of the HaemoLearn learning system data.
Essential Duties
- Conducts internal or external audits as assigned to ensure compliance to company quality system requirements.
- Generates daily, weekly, or monthly trending reports; seeks to improve reporting processes to ensure unified approach and procedures. Presents reports and materials at business unit meetings and updates reports as appropriate with any key issues or customer concerns
- Manages the process to gather and communicate quality systems Key Performance Indicators across the organization
- Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use
- Responsible in release of product to/from sterilization and to make disposition of the inspected component and product.
- Insures that full range of six sigma tools are used when appropriate for product and process changes in Braintree plan, particularly new products.
- 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.
- Leads product improvement projects and consults on supplier changes to ensure qualifications are met.
- Leads teams/projects related to Complaint investigation, NCE, cost reduction, and quality system excellence. Use of TQM tools including six sigma is required
- Review and approve test report, calibration logs, and any other documentations.
- Establish, maintain, review and approve documents/records to ensure compliance to GMP/ISO requirements
- May lead design review of new platforms and assures that appropriate tests are performed to achieve sigma level expectations for quality
- May maintain an active role in supplier and new business assessment and development.
- May manage and lead NCE/CAPA program, implementing global NCE/CAPA policies
- Required to have specific product or process expertise to fit business needs
- Comply with the ISO14001 Environmental Management System policy, SOP and requirements
- Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
- Perform other tasks as required.
Supervisory Responsibilities: None
Qualifications
Education
Bachelor's Degree: In Engineering/science or equivalent - Required
Experience
1 to 3 years or Fresh Graduate: In manufacturing environment or fresh graduate (as training will be provided) - Preferred
Skills
- Strong interpersonal skills required for interacting with external agencies and regulatory agencies to explain company policies, procedures and processes, with respect to their facility/product family is required
- Ability to communicate status performance of QMS to top management and to communicate regulatory and statutory requirements to all levels
- Demonstrate knowledge of problem solving techniques and statistics (e.g. six sigma methodology)
- Able to be depended and extremely attentive to accuracy and detail at work
- Proficiency with practical knowledge in ISO 13485, ISO 14001 Environmental Management System, FDA 21 CFR Part 820, EU Medical Device Directive requirements, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745), Good Distribution Practice for Medical Devices (GDPMD).
Training/Certifications
- ISO13485, 21 CFR 820 , 21 CFR 11 and GDPMD requirements
- Computer proficiency using Microsoft Work, Excel, or similar programs
- System/Tool Access:
- Component Engineer; Creator can read and discover object he or she created; Haemo Auditee; Haemo NCE Owner; Item Content Manager; Quality Administrator; Quality Analyst
- Auditing
Physical Demands
☑ 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.
Travel Expectations: Occasional 10-25%
EEO Policy Statement