Job Title: Quality Consultant
Location: Greater Phoenix Area
Duration: 6 Months (with potential extension to 12 months)
About the Company:
Our client is seeking a highly experienced Quality professional to join their dynamic team.
Position Overview:
The consultant will provide strategic guidance on quality systems, regulatory compliance, and process improvement, ensuring products meet the highest quality and regulatory standards. This role involves collaborating with internal teams and external partners to drive quality initiatives, mitigate risks, and support product development and commercialization.
Key Responsibilities:
- QMS Implementation:
- Design and implement Quality Management Systems compliant with ISO 13485, FDA 21 CFR Part 820, and other standards.
- Conduct gap analyses and provide recommendations for system improvements.
- Develop and refine quality procedures, policies, and documentation.
- Regulatory Compliance:
- Offer expert guidance on global regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and MDR.
- Assist with regulatory submissions and ensure documentation compliance.
- Audit and Inspection Readiness:
- Lead internal and external audits, including FDA inspections and ISO audits.
- Prepare the organization for regulatory inspections, conducting mock audits, and addressing audit findings.
- Process Improvement:
- Identify areas for quality process improvements and implement Lean Six Sigma methodologies.
- Provide training on quality improvement techniques.
- Risk Management:
- Conduct risk assessments and integrate risk management into product development.
- Support post-market surveillance and address emerging risks.
- Supplier Quality Management:
- Qualify suppliers and ensure they meet quality standards.
- Resolve quality issues and conduct supplier audits.
Qualifications:
- Bachelor’s degree in Engineering, Science, or related field; advanced degree preferred.
- 10+ years of quality engineering or consulting experience in the medical device industry.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and global regulations.
- Proven experience in QMS implementation and managing audits.
- Excellent problem-solving, communication, and interpersonal skills.
- Relevant certifications (CQA, CQE) are highly desirable.
This position would require FT support with the potential of a hybrid set up once established with the team and project.
