Quality Engineer II
This position will develop new and existing processes to incorporate Quality, ensure Quality Assurance capabilities upon implementation, and maintain/improve processes post-implementation. This position will also ensure that Design Controls, including Risk Management, are adhered to throughout all development activities (new products, new processes, & process improvements).
Minimum of four (4) years’ experience in a Quality role, preferably in the Medical Device Industry.
This position ensures that complies with and meets the standards of regulatory agencies as necessary.
Duties and Responsibilities
- Develop and maintain an understanding of the products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
- Communicate effectively with suppliers to resolve incoming documentation and quality issues
- Support Manufacturing activities from a Quality perspective in accordance with the requirements of 21 CFR § 820, 21 CFR § 1271, ISO 13485, and MDSAP (per jurisdictional areas)
- Perform Design Control activities such as Risk Management, trace matrixes, Verification & Validation, providing Quality input for design specifications, developing workflows, writing work instructions and SOPs, gate reviews, etc.
- Support existing product/process development by evaluating data from production, NCs/Complaints (with root cause investigation), and engineering studies. Drive for improvement by implementing meaningful process changes
- Lead efforts to identify quality gaps in the design of manufacturing-related processes and systems. Implement process improvements where quality is inherent, relevant, and effective within the processes. Develop new workflows that ensure quality throughout by implementing QC metrics within processes that minimize/eliminate preventable failure modes
- Identify areas of opportunity for continual improvement and lean manufacturing throughout the facility
- Support the efforts of QA/RA Management to achieve departmental goals and quality objectives
- Participate in the following QMS activities:
- Nonconforming Product Management
- Supplier Management
iii. Corrective and Preventive Actions
- Internal and External Audits
- Sterilization Validation/Dose Audits
- Other QMS activities such as batch record review and product inspection (as applicable)
- Participate in training plans and programs and complete in a timely manner within set deadlines
- Complete annual SOP review and OSHA safety training as applicable
- Train and monitor the training of others in Department activities. May review and maintain employee training records
- Write and revise a variety of technical documents including protocols, work instructions, standard operating procedures, forms, specifications, and training documents
- Minimum of a Bachelor’s degree from an accredited college or university in Engineering or related technical field of study
- Minimum of four (4) years’ experience in a Quality role, preferably in the Medical Device, Biologics, and/or pharmaceutical industries
- Minimum of one (1) year of experience leading and executing Medical Device Risk Management and Design Control processes
- Quality certifications (e.g., CQT, CQPA), Lean manufacturing and/or Six Sigma certifications are preferred
- Advanced knowledge of FDA, ISO, & AATB regulations and guidance (e.g., Design Controls, Risk Management, GxP)
- Technical writing proficiency for creating, reviewing, approving protocols/reports, work instructions, forms, and SOPs
- Advanced knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments. Advanced knowledge of volume and routine-manufacturing operations
Position based in the West but will be remote.
For more information please send an updated resume to email@example.com. Qualified candidates will be contacted promptly.