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%
Skills Required
- Bachelor's degree in quality or a related field, or an equivalent combination of education, certifications, and experience
- ASQ CQE or CMQ/QE certification
- Four years of quality experience in the medical device manufacturing industry
- Experience with ISO 13485, FDA 21 CFR Part 820, and customer interactions
- 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 and GD&T skills
- Problem-solving and 8D experience
- Algebra and trigonometry skills
- Microsoft Office proficiency, including Word, Excel, Outlook, and PowerPoint
What We Do
Tecomet is a global leader in the design, development, and manufacture of orthopedic and minimally invasive surgical products, as well as precision components for the aerospace and defense industries. They provide full-spectrum, scalable manufacturing solutions for medical device technology, aerospace, and defense companies, focusing on technical expertise, high-precision engineering, and exceptional quality to bring flawless products to market.
