- Bachelors degree in engineering (or science-focused).
- 5-7 years of experience in quality engineering within the medical device or life science industry.
- Experience with medical device design and development processes.
- Strong knowledge of quality management systems, design control processes, risk management, and regulatory compliance (e.g., FDA 21 CFR Part 820, ISO 13485, ISO
- Software/software quality experience IEC62304 (software development lifecycle).
- Experience managing and evolving a Quality Management System.
- Design quality experience experience with medical device design and development
- Root cause analysis skills to address issues and inefficiencies in existing processes.
- Leadership skills to guide teams through the CAPA process, ensuring accountability and ownership of tasks.
- Experience with audits of a Quality Management System.
- Excellent problem-solving skills and attention to detail.
- Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.
- Certification in Quality Engineering (e.g., ASQ Certified Quality Engineer) is a plus.
- Auditor certification is a plus.
- Experience evaluating and selecting tools for managing a Quality Management System.
- Document control process (controlling SOPs and quality records) experience and skills.
- Regulatory and submission experience.
- ISO 14971 risk management and performing risk analysis experience.
- Design Verification & Validation experience.
- Project Manager experience.
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Senior Quality Engineer - Southborough, United States - Full Spectrum Services
1 week ago
Description
About Us: Full Spectrum (FS) is a leading engineering services company dedicated to delivering high-quality products and services that meet and exceed customer expectations. We are currently seeking a skilled and proactive Senior Quality Engineer to join our dynamic team and contribute to our commitment to excellence and innovation.
Job Overview: As a Senior Quality Engineer at FS, you will play a key role in supporting the evolution of the FS Quality Management System, as well as working directly with FS teams on our client engagements. Your expertise will be critical in identifying areas for improvement for FS and our clients, implementing best practices, and ensuring compliance with regulatory requirements and standards.
Key Responsibilities:
Evolution of FS Quality Management System (35-50%):
Work closely with the FS business units ensuring we meet ISO 13485 and 9001 standards, as well as IEC 62304 and other applicable standards.
Lead and participate in process improvement initiative to enhance quality and efficiency of the FS Quality Management System.
Work with cross-functional teams to develop and implement quality processes, procedures, work instructions, and templates.
Develop and execute effective internal QMS training framework.
Support internal and external audits to ensure compliance with quality standards.
Lead quarterly QMS Change Management Board meetings and quarterly QMS releases; drive resolution of internal CAPAs.
Evaluate, select, and implement an eQMS to improve efficiency of issue and CAPA tracking, document management, and training execution and tracking.
Stay current with industry best practices, regulations, and emerging trends in quality engineering. Apply this knowledge to drive continuous improvement initiatives within the organization.
Billable work with FS teams on client engagements (50-65%):
Apply your experience to billable client engagements. Depending on your background, this work could include joining an FS project team to:
Develop and maintain Design Control documentation, including Design History Files, Risk Management Files, and Change Control Records.
Lead design reviews and provide quality engineering input to the product development process, ensuring that designs are optimized for manufacturability and meet customer requirements.
Participate in the development of verification and validation protocols and oversee the execution of these protocols to ensure that products meet design specifications and performance requirements.
Perform a Project Manager role and lead the execution of FS team activities, manage budget, scope, and schedule, and interface with the client to communicate status and raise and resolve risks and issues.
Qualifications:
Nice to haves:
