Meridian Bioscience, Inc

Senior Quality Assurance Engineer

Meridian Bioscience, Inc • $120K — $140K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor of Science Degree in Engineering or Science
  • 4+ years experience in OEM medical device manufacturing (FDA approved/510k cleared)
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
  • In-depth knowledge of GMP, FDA regulations (21 CFR Part 820), and ISO 13485
  • Experience in writing and executing deviations, nonconformance reports, CAPAs, and complaints
  • Familiarity with electronic document management systems preferred
  • Strong critical thinking and troubleshooting skills
  • Excellent written and verbal communication skills
  • Good organizational skills with attention to detail
  • Ability to work independently and adapt to a fast-paced environment
  • Willingness to travel up to 5%

Responsibilities

  • Provide expertise in Risk Management and Design Verification/Validation
  • Drive Design Assurance activities throughout product lifecycle management
  • Ensure compliance with U.S. and international regulations (21 CFR 820, IVDR, ISO 13485)
  • Maintain and enhance quality management systems to meet regulatory requirements
  • Develop and validate test methods and inspection procedures
  • Identify and implement continuous improvement and CAPA projects
  • Support supplier quality management through audits and maintaining the Approved Supplier List
  • Apply systematic methodologies to resolve quality issues
  • Lead Manufacturing Review Board (MRB) and Nonconformance activities
  • Participate in internal/external audits to maintain regulatory compliance
  • Support complaint handling and design control activities as needed
  • Generate quality metrics and perform trend analysis for improvements

Benefits

  • Comprehensive healthcare plans
  • 401(k) plan with company match
  • Paid time off and holidays
  • Opportunities for professional development
  • Flexible working hours
  • Travel allowance up to 5%
Full Job Description
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.

About Meridian Bioscience, Inc

Meridian Bioscience, Inc. 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. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We are headquartered in Cincinnati, OH.
Learn more about Meridian Bioscience, Inc
Size
765 employees
Market Cap
$1.4 billion
Industry
Pharmaceuticals & Biotech
Net Income
$46.1 million
Founded
1977
5 Year Trend
+10.7%
Revenue
$299.1 million
NASDAQ
VIVO
* Ladders Estimates

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