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Junior Quality Assurance Engineer
2 months ago
Merrimack Manufacturing is seeking a highly skilled Quality Assurance Specialist to support the development and implementation of quality management systems in a fast-paced, medical device-manufacturing environment.
Key Responsibilities- Quality Management System Development: Develop and maintain control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity.
- New Product Introduction: Leverage engineering and technical expertise to evaluate new products, manufacturing processes, and ensure compliance with applicable regulatory standards throughout the NPI process.
- Project Leadership: Lead project teams through protocol generation, execution, documentation organization, report writing, and meeting schedule for final approval and release for use.
- Investigation and Root Cause Analysis: Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem-solving skills.
- Validation and Verification: Lead the evaluation and identification of validation requirements and sampling plans for new, and changes to, manufacturing processes, test methods, and equipment.
- Process Improvement: Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction.
- Device Master Records and Risk Management: Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products.
- Manufacturing Equipment Evaluation: Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met.
- Quality Management System Improvement: Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing's Quality Management System.
- Material Review Board and Audits: Participate in Material Review Board (MRB) meetings, track and follow through with nonconformance reports assigned, and support and contribute towards the success of external audits.
- Bachelor's degree in a relevant technical field or equivalent experience.
- At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industries.
- Strong knowledge of CFR Part 820 and ISO 13485.
- Lean and Six Sigma certification preferred.
- Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications.
- Knowledge of New Product Introduction processes and deliverables.
- Strong knowledge of tolerance stack up calculations and calibration best practices.
- Strong organization, communication, and time management skills; Project Management experience preferred.
- Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation preferred.