Senior Quality Engineer – Aerospace Quality & Six Sigma

Orchid Orthopedic Solutions LLC; Wilmington (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Orchid Orthopedic Solutions LLC in Wilmington, MA seeks a Sr. Quality Engineer to ensure compliance with AS9100/ISO13485, GMP, and customer requirements. You will drive quality initiatives, resolve issues with manufacturing, and lead CAPA investigations.

Ideal candidates have a quality background in aerospace/defense, ASQ CQE preferred, and a proactive approach to process improvements and documentation. This role involves audits and cross-functional coordination.

Qualifications

• Bachelor's degree in quality or related field or equivalent experience.
• ASQ CQE or CMQ/QE preferred.
• 4 years' quality experience in aerospace/defense preferred.

Responsibilities

• Maintain quality systems including AS9100 or ISO 13485 and GMP regimes.
• Support MRB, RMA processes and CAPA investigations.
• Collaborate with manufacturing to resolve quality, cost and schedule issues.
• Prepare FMEAs, control plans, quality plans, and PPAPs.
• Coordinate process validations and reduce inspection reliance.
• Generate quality metrics and drive cost of quality improvements.
• Lead audits, supplier and customer interactions and document actions.
• Write and maintain quality instructions and procedures.
• Manage ITAR and CUI controls as required.

Skills

Manufacturing operations

Measuring devices

Quality systems

Regulations

Blueprint reading

GD&T

Problem solving (8D)

Math skills

MS Office

Education

Bachelor's degree in quality or related field

Job description

Orchid Orthopedic Solutions LLC in Wilmington, MA seeks a Sr. Quality Engineer to ensure compliance with AS9100/ISO13485, GMP, and customer requirements. You will drive quality initiatives, resolve issues with manufacturing, and lead CAPA investigations.

Ideal candidates have a quality background in aerospace/defense, ASQ CQE preferred, and a proactive approach to process improvements and documentation. This role involves audits and cross-functional coordination.