Sr. Quality Engineer

Tecomet, Inc • Wilmington, MA

4d

About The Position

The Sr. Quality Engineer works with team members to ensure compliance with internal and external customer requirements, with a focus on quality engineering. The role supports Tecomet’s principles of continuous improvement, customer-driven innovation, and a win-first culture while meeting company financial and other performance metrics.

The engineer maintains applicable quality-system, environmental, and FDA requirements and certifications; supports manufacturing and operations in resolving quality, cost, and schedule issues; and contributes to quality planning, process validation, customer complaint investigation, audits, and inspections. The position also applies manufacturing knowledge, regulatory requirements, statistical and Six Sigma concepts, and standard problem-solving techniques. Travel is up to 10%.

Requirements

• Bachelor’s degree in quality or a related field, or a combination of education, certifications, and experience.
• Knowledge of manufacturing operations, including forging and/or machining.
• Knowledge of measuring devices and quality systems.
• Knowledge of FDA, GMP, and ISO regulations.
• Blueprint-reading skills.
• Knowledge of GD&T.
• Problem-solving and 8D skills.
• Math skills, including algebra and trigonometry.
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint.

Nice To Haves

• ASQ CQE or CMQ/QE certification.
• Four years of quality experience in the medical device manufacturing industry.
• Experience with ISO 13485, FDA 820, and customer interaction.

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements and certifications.
• Facilitate the operator-owned quality program.
• Support the MRB and RMA processes.
• Work with team members and support manufacturing and operations to resolve quality, cost, and schedule issues.
• Prepare FMEAs, control plans, quality plans, and PPAPs.
• Coordinate process validations and reduce dependence on inspection.
• Generate applicable quality metric reports, including cost of quality and management-by-facts reporting.
• Investigate customer complaints and associated actions, including CAPA, deviations, and complaint responses.
• Complete special projects assigned by quality management.
• Apply working knowledge of standard manufacturing operations, FDA and ISO regulations, GMP and GDP requirements, and standard problem-solving techniques.
• Apply statistical and Six Sigma concepts and techniques.
• Work with internal and external customers.
• Participate in audits and inspections.
• Write and maintain quality-related work instructions and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior