Job Summary
- Location
- San Diego, CA 92121
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- BST1538
Principle Quality Engineer
About the Job
Position Description:
The Principle Quality Engineer will be supporting new product/process development projects, technology transfers, and existing products/processes.
Tasks and responsibilities:
•Responsible for ensuring external Quality System Requirements and internal Quality System requirements are adhered to throughout product and process lifecycles. This includes products in design and development as well as products on market and the processes which support them.
•Lead teams through risk based approach for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities.
•Provide guidance to cross functional team on how to document changes, use risk based approach for determining validation or verification requirements and documentation requirements. Review and approve changes ensuring compliance with internal and external standards.
•Ensure compliance in manufacturing areas, escalate nonconforming situations. Lead root cause investigations, provide guidance on documentation for non-conformities, review non-conformities for compliance and presence of objective evidence.
•Conduct GMP audits in manufacturing areas, resolve and implement solutions for non-compliances. Identify areas for process and compliance improvement and implement changes. Implement improvements and methods for measuring effectiveness of changes.
•Develop and execute training on Good Documentation Practices, Good Laboratory Practices, Good Manufacturing Practices and annual Quality System training.
•Assist with investigations of complaints received through CAPA, post market surveillance, and product support as required to determine deficiencies in product and manufacturing processes. Assess and ensure compliance of design control, risk management, adequacy of testing and process and production control systems with applicable ISO/EN standards, FDA, QSR, European MDD, and applicable international requirements.
•Perform audits on various Quality System documents including but not limited to DHF files, DMRs, risk management files, batch records, change management files in accordance with internal and external standards.
•Author validation or verification protocol, reports, audit reports and standard operating Compile and analyze data and information for Quality Management Reviews and external audits. Perform trending on key Quality System metrics.
•Proactively identify quality system improvements; lead the development and implementation of quality system improvement projects including by not limited to training, labeling, risk management, process and production control, measurement/inspection techniques and internal auditing.
•Support LEAN manufacturing activities as required.
•Analyze and solve unusually complex problems which require sophisticated analysis, research techniques, or application of compliance principles.
•Understands the impact of decisions and actions within a quality system environment and communicates that cross-functionally and to junior employees.
•Participates in the development of junior employees by facilitating training and providing feedback and guidance. May lead a project team.
•Broad knowledge of federal and other regulations, e.g. QSRs, IVDD, ISO 13485, CMDR, etc.
•Perform other duties & projects as assigned.
To apply, please visit - Inverness Medical Innovations
Qualifications:
Preferred educational background:
BS/BA degree in science or technical discipline.
Preferred experience:
•8-12 years related experience.
•Comprehensive knowledge of multiple technical disciplines.
•Experience with federal, 3rd party agencies or regulatory agencies, e.g. QSR’s, ISO, ISO 13485, CMDR) and statistical sampling plans.
•Ability to work on and lead multidisciplinary teams.
•Identify and address compliance issues with medium to high complexity.
•Demonstrate problem-solving and troubleshooting skills
•Strong verbal and written communication skills
•Organized and detail oriented
Demonstrate understanding of business interactions across functions.
The Principle Quality Engineer will be supporting new product/process development projects, technology transfers, and existing products/processes.
Tasks and responsibilities:
•Responsible for ensuring external Quality System Requirements and internal Quality System requirements are adhered to throughout product and process lifecycles. This includes products in design and development as well as products on market and the processes which support them.
•Lead teams through risk based approach for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities.
•Provide guidance to cross functional team on how to document changes, use risk based approach for determining validation or verification requirements and documentation requirements. Review and approve changes ensuring compliance with internal and external standards.
•Ensure compliance in manufacturing areas, escalate nonconforming situations. Lead root cause investigations, provide guidance on documentation for non-conformities, review non-conformities for compliance and presence of objective evidence.
•Conduct GMP audits in manufacturing areas, resolve and implement solutions for non-compliances. Identify areas for process and compliance improvement and implement changes. Implement improvements and methods for measuring effectiveness of changes.
•Develop and execute training on Good Documentation Practices, Good Laboratory Practices, Good Manufacturing Practices and annual Quality System training.
•Assist with investigations of complaints received through CAPA, post market surveillance, and product support as required to determine deficiencies in product and manufacturing processes. Assess and ensure compliance of design control, risk management, adequacy of testing and process and production control systems with applicable ISO/EN standards, FDA, QSR, European MDD, and applicable international requirements.
•Perform audits on various Quality System documents including but not limited to DHF files, DMRs, risk management files, batch records, change management files in accordance with internal and external standards.
•Author validation or verification protocol, reports, audit reports and standard operating Compile and analyze data and information for Quality Management Reviews and external audits. Perform trending on key Quality System metrics.
•Proactively identify quality system improvements; lead the development and implementation of quality system improvement projects including by not limited to training, labeling, risk management, process and production control, measurement/inspection techniques and internal auditing.
•Support LEAN manufacturing activities as required.
•Analyze and solve unusually complex problems which require sophisticated analysis, research techniques, or application of compliance principles.
•Understands the impact of decisions and actions within a quality system environment and communicates that cross-functionally and to junior employees.
•Participates in the development of junior employees by facilitating training and providing feedback and guidance. May lead a project team.
•Broad knowledge of federal and other regulations, e.g. QSRs, IVDD, ISO 13485, CMDR, etc.
•Perform other duties & projects as assigned.
To apply, please visit - Inverness Medical Innovations
Qualifications:
Preferred educational background:
BS/BA degree in science or technical discipline.
Preferred experience:
•8-12 years related experience.
•Comprehensive knowledge of multiple technical disciplines.
•Experience with federal, 3rd party agencies or regulatory agencies, e.g. QSR’s, ISO, ISO 13485, CMDR) and statistical sampling plans.
•Ability to work on and lead multidisciplinary teams.
•Identify and address compliance issues with medium to high complexity.
•Demonstrate problem-solving and troubleshooting skills
•Strong verbal and written communication skills
•Organized and detail oriented
Demonstrate understanding of business interactions across functions.
