Sr. Quality Engineer

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

Sr. Quality Engineer

Position Summary

The Sr. Quality Engineer will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet's principles of continuous improvement, customer driven innovation and a win-first culture, while meeting company financial and other performance metrics.

Principle Responsibilities

• Maintaining applicable quality system, environmental, and AS9100 or ISO 13485.
• Facilitate operator owned quality program.
• Supporting the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA's, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
• Special projects assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, AS and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques.
• Applies statistical and Six Sigma concepts and techniques.
• Works with Internal and External Customers.
• Participates in audits and inspections.
• Writing and maintaining quality related work instructions and procedures.
• Manages ITAR and CUI controls.

Qualification Requirements

Credentials/Experience:

• Bachelor's degree in quality or related field and/or a combination of education, certifications and experience will be considered

Experience/Educational/Training Preferred:

• ASQ CQE or CMQ/QE preferred
• 4 years' experience in quality within aerospace/defense industry preferred
• AS9100 or ISO 13485, FDA 820 and customer interaction experience preferred

Knowledge, Skills, and Abilities:

• Manufacturing operations - forging and/or machining.
• Measuring devices.
• Quality Systems.
• Regulations - FDA, GMP and ISO.
• Blueprint reading.
• GD&T.
• Problem solving and 8D.
• Math skills (algebra, trigonometry) skills.
• Microsoft office (Word, Excel, Outlook, PowerPoint).

Other Requirements

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10%