QA Engineer

bioMérieux • Philadelphia, PA

7d • Onsite

About The Position

The QA Engineer, Document Control Specialist is responsible for supporting the full Quality Management System (ISO 9001 based) at the Philadelphia site under the guidance of the Quality Associate Manager. This role involves executing the Quality function for verifying and maintaining records for non-conformances, deviations, root-cause-investigations, change controls, CAPAs, and complaints. It also includes the maintenance of quality system records, assisting employees with document numbering, maintaining Doc. Control KPIs, assisting with continuous improvement programs, aiding in employee training, and completing data entry in quality databases. All work must be performed in compliance with company quality procedures and standards.

Requirements

• Bachelor's degree required Life Sciences, Engineering, Quality, or related field required
• 2+ years of professional related experience with degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
• 6+ years of professional related experience in lieu of degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
• Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance

Nice To Haves

• Prior experience executing and building a Quality Management Systems procedures and document control is preferred.
• Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO9001, ISO13485, ISO17025) is a plus.
• Experience managing nonconformances, investigation writing experience and change control preferred
• Demonstrated experience in manufacturing operations is preferred
• Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.

Responsibilities

• Executing the Quality function for verifying and maintaining records as directed for non-conformances, deviations, root-cause-investigations, change controls, CAPAs complaints as defined within local procedures.
• Maintenance of quality system records including preparation, verification and filing of Quality documentation to ensure that it meets applicable customer, regulatory, and corporate requirements.
• Assist employees in obtaining identification numbering for internal and external documents, and controlled documentation.
• Responsible for maintaining Doc. Control KPIs.
• Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
• Assist in employee training and maintain employee training records under the QMS.
• Complete data entry in quality databases for new and modified documents.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Benefits

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level