Manager of QA Compliance overseeing Quality Agreements in biotech firm BridgeBio Pharma. Collaborating cross - functionally for compliance and inspection readiness in FDA - regulated environments.
About the role
- Supplier Quality Engineer overseeing contract manufacturers' quality control at PurposeBuilt Brands. Collaborating with teams to drive process improvements and ensure compliance with standards.
Responsibilities
- Maintain detailed reports related to contract manufacturers quality performance
- Provide technical guidance and advice to suppliers and decision-maker
- Communicate between contract manufacturers and senior management to identify issues in contract manufactured quality and provide guidance and lead process enhancements and improvements projects
- Function as part of a supplier assessment team performing on-site inspections of quality system audits at suppliers and evaluate partner suitability and to drive process standardization, waste elimination and continuous improvement.
- Perform on-site and internal supplier development activities and continuous improvement initiatives with key partners
- Facilitate problem solving and root cause analysis to eliminate recurrence of non-conformance
- Help establish, monitor, and improve key performance indicators at contract manufacturers
- Work to resolve contract manufacturing technical issues in a timely manner to ensure continuity of supply
- Performs Document Control processes to ensure all Procedures are properly documented, updated as needed and in compliance with regulatory requirements.
- Coordinate chemical and microbial testing of finished products
- Prepare data for quarterly supplier reviews
- Lead Supplier Corrective Action Requests (CAPA)
- Work with contract manufacturers and internal teams to resolve quality issues
- Participate in pilot and/or first product runs performed by contract manufacturers
Requirements
- BS/BA in related discipline, or advanced degree, preferred or equivalent combination of education and experience.
- Typically, 3-5 years of experience in a Quality role
- ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA), Six Sigma Green or Black belt is a plus
- Knowledge of applicable Quality System requirements (GMP and ISO 9001) is strongly desired
- Ability to manage multiple projects/activities; results driven
- Excellent communication and interpersonal skills.
- Proficiency with MS Office Products (Word, Excel, PowerPoint, etc.)
Benefits
- Flexible work options (fully remote, hybrid, onsite)
- Generous paid time off
- Competitive salaries and bonus incentives
- 401K company match
- Competitive medical, dental, & vision insurance
- Pet insurance
- Annual fitness stipend
- Unmatched employee discount on all products
- Summer Hours
- LinkedIn learning membership
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Quality Assurance Specialist II ensuring compliance with regulatory requirements and industry standards for health - related products. Develops quality assurance activities and supports audits and investigations.
Compliance Testing Manager responsible for independent testing oversight and Compliance program development at TD Bank. Leading QA processes and collaborating with compliance teams for effective risk management.
QA Manager ensuring quality processes across Grow's platform for reliable healthcare experiences. Collaborating with Product, Engineering, and Design to facilitate product development and quality assurance.
PCB Tester ensuring the quality and functionality of printed circuit boards at Kentec Electronics. Working in a manufacturing team to conduct tests and maintain standards.
Supplier Quality Engineer at Heraeus Medevio responsible for supplier compliance and quality processes ensuring raw materials meet specifications. Supports continuous improvement and audits supplier quality standards.
QA Engineer coordinating process development and validation projects at Heraeus Medevio. Ensuring compliance and timely transfers in the Medical Industry.
Global QA Specialist managing the quality of IVD medical devices manufacturing for Grifols. Harmonizing quality systems, ensuring compliance, and supporting audits.
Quality Assurance Engineer ensuring compliance for engineering in UK's submarines and warships. Role involves oversight and collaboration to meet safety and reliability standards.
Senior Quality Engineer ensuring software quality and reliability through comprehensive test planning and execution at NTT DATA Romania. Collaborating within Agile environments for test automation and performance testing, alongside other QA experts.