- Provide expertise in Quality Management System design and implementation, Manufacturing Quality, Risk Management, Process Validation, Design Verification and Validation, Statistical Methods and Design and Change Controls.
- Drive quality system execution to U.S. regulations (21 CFR 820), International regulations and standards (IVDR, ISO 13485, and other international requirements).
- Develop and maintain QA standard operating procedures (SOP) and review SOPs generated by other departments.
- Subject matter expert for quality requirements related to manufacturing and product/process changes. Will review, provide guidance, and support proposed product and processes changes, ensuring that the necessary quality standards are met.
- Drive improvements to the Quality Management System and related process with a focus on Manufacturing Quality.
- Support Manufacturing and Process Engineering on continuous improvement projects in Manufacturing, Quality Control, Testing and Verification/Validation.
- Manage the Internal Audit Program, perform internal audits as necessary, assist in resolving observations, and provide support for audits and inspections from Regulatory Authorities.
- Manage the processes for resolving and documenting Corrective and Preventative Actions, and document and process changes.
- Support the development of key performance indicators for the Quality Management System and track performance against goals, identify trends, for continuous improvement purposes and Quality Review Board presentations.
- Support Technical Services in complaint review and trending, to ensure that the Risk Management documentation sufficiently addresses potential problems, to identify trends in customer complaints that reflect manufacturing quality issues, previously unidentified issues, or increases in occurrence of complaints generally, and for specific complaint types.
- Support Regulatory Affairs in identifying, investigating, and documenting complaints that are reportable under US and International Regulations.
- Assist in Out of Specification (OOS) investigations to improve product quality and/or production processes, initiate and complete Nonconforming Product documentation.
- Initiating quarantine of product and help establish the disposition of product.
- Communication with Suppliers related to Quality Issues and supporting Supplier Management
- Other duties as assigned to support the business.
- Light Physical requirements: sitting for long periods, walking short distances indoors, light lifting associated with typical office environment activities.
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Sr. Quality Systems - North Billerica, United States - Meridian Bioscience
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 expertise and support to ensure the quality of design, sourcing and manufacturing of products meets or exceeds all internal and external requirements and standards.
Proactively participate in product development projects to support compliant processes and documentation in new product development and for design changes.
Develop, establish, and maintain well-established quality processes, methodologies, documentation systems and practices to meet customer and regulatory requirements.
Key Duties:Tasks/Duties/Responsibilities:
Other duties as assigned:
Minimum Education or Equivalent Experience Required/Preferred
Bachelors Degree required, preferably in Engineering, a medical technology (Clinical Chemistry, Medical Technology, etc.), or a relevant Science (Biology, Chemistry, Physics, etc.)
Advanced degree preferred but not required.
At least 7 years of experience in OEM medical device manufacturing of FDA approved or 510k cleared product.
Competencies Required or preferred
Preferred direct experience with ISO 13485 auditing, CAPA processes, and creating procedures and creating/improving Quality Management Systems.
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
Required Travel %:
Potential for infrequent travel, less than 20%, to Corporate Headquarters, training locations, or vendor facilities.
*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*
