Sr. Quality Engineer

About the role

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

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator-owned quality programs.
• Support the Material Review Board (MRB) and Return Merchandise Authorization (RMA) processes.
• Collaborate with team members and support manufacturing/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 quality metric reports, including cost of quality and management by facts.
• Investigate customer complaints and associated actions, including CAPA, deviations, and complaint responses.
• Handle special projects as assigned by quality management.
• Demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), 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.

Qualifications

• Bachelor’s Degree in Quality or a related field, or a combination of education, certifications, and experience.
• Preferred: ASQ CQE or CMQ/QE certification.
• Preferred: 4 years of experience in quality within the medical device manufacturing industry.
• Preferred: Experience with ISO 13485, FDA 820, and customer interaction.

Knowledge, Skills, and Abilities

• Manufacturing operations: forging and/or machining.
• Use of measuring devices.
• Quality systems expertise.
• Regulatory knowledge: FDA, GMP, and ISO.
• Blueprint reading and Geometric Dimensioning & Tolerancing (GD&T).
• Metrology.
• Problem-solving and 8D methodology.
• Mathematical skills (algebra, trigonometry).
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with Minitab.

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

Travel Requirements

Up to 10%.