Quality Engineer III

SGS Consulting; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

SGS Consulting seeks a seasoned quality professional to drive process and product characterization for continuous improvement in a manufacturing setting. You will handle NC reports, CAPAs, and supplier-related issues while performing audits to ISO-13485 and FDA standards.

Strong data analysis and risk mitigation experience are essential. Minimum 8+ years in manufacturing/quality, with degrees ranging from Bachelor's to Doctorate as noted.

Qualifications

• Experience in manufacturing/operations required.
• FDA and ISO risk management knowledge required.
• Certified Internal Auditor to ISO-13485.

Responsibilities

• Support quality improvement initiatives for process and product characterization.
• Work on non-conforming (NC) reports and CAPA review and close.
• Conduct internal and supplier audits per ISO standards.
• Analyze data and perform statistical analyses for improvements.
• Escalate quality issues and own material identification and defect classification.

Skills

Risk management

ISO-13485 Internal Audit

Manufacturing/Operations

Statistical analysis

Education

Bachelor's degree +8+ years

Master’s degree +5+ years

Doctoral degree +3+ years

Job description

Job Responsibilities

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close). Work with third party suppliers to resolve issues with NC. Conduct Internal/Supplier Audits of the facility per ISO-1385 and/or 21CFR820. Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. It is also understood that an associate may receive special projects outside of this list.

Skills

This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. Experience with a proven track record of implementing appropriate risk mitigation. Certified Internal Audit to ISO-13485. Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.

Education/Experience

Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, master’s degree with 5+ years of experience, Doctoral degree with 3+ years of experience