Senior Quality Assurance Engineer

Meridian Bioscience Inc.; North Billerica (MA); On-site; USD 120,000 - 140,000; Full time

Job summary

Meridian Bioscience Inc. in North Billerica, MA is seeking a Quality Engineer to provide quality engineering support for design, sourcing and manufacturing of diagnostic products.

You will participate in product development teams as a Quality core team member and help establish and maintain quality systems to meet regulatory requirements. Responsibilities include risk management, design verification/validation, process validation, CAPA, and supplier quality; travel up to 5% as needed;

Qualifications

• Bachelor of Science Degree in Engineering or Science.
• At least 4 years’ experience in OEM medical device manufacturing of FDA approved or 510k cleared product.
• Extensive working knowledge of GMP, FDA regulations (21 CFR Part 820), ISO 13485.
• Ability to write, review, and execute deviations, nonconformance reports, CAPAs, and complaints.
• Previous experience with electronic document management systems preferred.
• Ability to read, understand and follow all company SOPs and guidelines.

Responsibilities

• Provide expertise in Risk Management, Design Verification and Validation, Process Validation, Statistical Methods and Design Controls.
• Drive Design Assurance activities throughout Product Life Cycle management.
• Drive quality system execution to U.S. regulations (21 CFR 820), International regulations and standards (IVDR and ISO 13485).
• Assist in maintaining and improving the quality management system documentation and processes to meet or exceed all applicable requirements.
• Develop and validate test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
• Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
• Support supplier quality management, including maintaining the Approved Supplier List, performing audits of sub-contractors and material / component suppliers.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Execute and review engineering change orders and document change requests.
• Facilitate product risk management activities (e.g., Risk Management Plans, Risk Management Reports, Risk Management Files, Hazard Analyses, FMEAs).
• Identify, prioritize, communicate and resolve quality issues given dynamic business needs.
• Identify and implement effective process controls to support the development, qualification, and manufacturing of products.
• Generate quality metrics, perform trend analyses, and identify preventive / corrective actions to drive product quality and process improvements through the CAPA process or other methods.
• Participate in developing inspection requirements for procured and manufactured products.
• Lead MRB and Nonconformance activities
• Participate in internal and external audits and other quality system maintenance/improvement activities to be compliant with various regulatory standards and regulations, such as Management Review
• Provide support to the complaint handling function as required
• Provide support in design control activities as required.
• Perform other duties as assigned

Skills

Regulatory compliance

CAPA management

Risk management

Quality systems

Problem solving

Technical writing

Education

Bachelor of Science in Engineering or Science

Tools

Microsoft Office

Job description

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

Provide quality engineering support to ensure the quality of design, sourcing and manufacturing of products at Magellan meets or exceeds all internal and external requirements and standards. Proactively participate in product development teams as the Quality core team member. Develop, establish, and maintain well-established quality engineering methodologies, systems and practices to meet customer and regulatory requirements.

Key Duties

• Provide expertise in Risk Management, Design Verification and Validation, Process Validation, Statistical Methods and Design Controls.
• Drive Design Assurance activities throughout Product Life Cycle management.
• Drive quality system execution to U.S. regulations (21 CFR 820), International regulations and standards( IVDR and ISO 13485)
• Assist in maintaining and improving the quality management system documentation and processes to meet or exceed all applicable requirements
• Develop and validate test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
• Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
• Support supplier quality management, including maintaining the Approved Supplier List, performing audits of sub-contractors and material / component suppliers.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Execute and review engineering change orders and document change requests
• Facilitate product risk management activities (e.g., Risk Management Plans, Risk Management Reports, Risk Management Files, Hazard Analyses, FMEAs)
• Identify, prioritize, communicate and resolve quality issues given dynamic business needs
• Identify and implement effective process controls to support the development, qualification, and manufacturing of products.
• Generate quality metrics, perform trend analyses, and identify preventive / corrective actions to drive product quality and process improvements through the CAPA process or other methods.
• Participate in developing inspection requirements for procured and manufactured products.
• Lead MRB and Nonconformance activities
• Participate in internal and external audits and other quality system maintenance/improvement activities to be compliant with various regulatory standards and regulations, such as Management Review
• Provide support to the complaint handling function as required
• Provide support in design control activities as required.
• Perform other duties as assigned

Qualifications

• Bachelor of Science Degree in Engineering or Science
• At least 4 years’ experience in OEM medical device manufacturing of FDA approved or 510k cleared product
• Able to use Microsoft Office (Microsoft Word, Excel, PowerPoint)
• Extensive working knowledge of GMP, FDA regulations (21 CFR Part 820), ISO 13485
• Ability to write, review, and execute deviations, nonconformance reports, CAPAs, and complaints.
• Previous experience with electronic document management systems preferred
• Ability to read, understand and follow all company SOPs and guidelines.
• Utilize critical thinking skills to problem solve and troubleshoot.
• Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
• Good organizational skills and strong attention to detail.
• Must be able to perform job requirements independently with minimal supervision.
• Adjusts easily and readily to a fast-paced work environment with changing priorities
• Travel up to 5%
• Compensation: $120k to $140k with a 7% target bonus.