What are the responsibilities and job description for the Quality Engineer position at Tecomet, Inc.?
Quality Engineer
Build innovative solutions and design the future.
You can pursue your potential at Tecomet by working with a dedicated team to solve complex challenges, in partnership with industry-leading clients in medical device technology, aerospace, and defense industries. With the backing of our steadfast brand, you can be a part of the next era of manufacturing by bringing bold ideas to life and building products that improve on the status quo.
What’s In It For You:
At Tecomet, we believe that everyone makes a difference and contributes to our overall success. We are a team bound together by pride in our work and dedication to our craft. Our leadership team shares the company’s strategic direction so our workforce can remain informed and attain our internal goals and objectives.
Let’s talk about what we have to offer:
Competitive pay and benefit packages
Health Benefits start on day one
401k available with matching
9 Paid Holidays with 2 Floating Holidays
PTO offered
POSITION SUMMARY:
The Quality Engineer ensures the quality-related requirements from our customers are communicated clearly and concisely to manufacturing and engineering. The Sr. Quality Engineer works to ensure compliance to applicable regulations and standards, reduce overall manufacturing quality costs to increase profitability, to meet internal and external customer requirements and to teach quality sciences to team members. 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.
PRINCIPAL RESPONSIBILITIES:
Maintain applicable quality system, environmental, and FDA requirements/certifications.
Review customer quotes for overall quality requirements.
Coordinate process validations and reduce dependence on inspection.
Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
Generate applicable quality metric reports, cost of quality, management by facts.
Support the MRB and RMA processes, performing disposition of materials.
Determine/improve inspection methods/instructions and incorporate them into the manufacturing process and Quality Plans.
Develop and maintain FMEA’s, control plans, quality plans, PPAP.
Investigate customer complaints including CAPA, deviations, and complaint responses.
Follow-up on all internal and external corrective action responses.
Establish and maintain a system that triggers effective corrective action.
Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques.
Proficient in full and proper Geometric Dimensioning & Tolerancing (GD&T) application, and blueprint reading.
Works with Engineering to conceptualize and develop gauging. Applies basic statistical and Six Sigma concepts and techniques.
Consult with manufacturing engineers in resolving quality-related issues.
Determines and develops inspection methods, participates in Material Review Board (MRB) meetings, and establishes internal and external corrective actions.
Works with Internal and External Customers, as well as participates in audits.
Adjust and prioritize work to meet deadlines while maintaining quality standards.
Conduct training on topics of Company and customer SOPs.
Special projects as assigned by the Quality Manager.
EDUCATION AND EXPERIENCE REQUIRED
Bachelor's degree in engineering or biomedical or combination 5 years of quality experience and associate’s degree in engineering or biomedical field or high school diploma/GED and 7 years of quality experience
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED
Manufacturing operations – machining
Measuring devices
Quality Systems
Regulations – FDA / ISO
Part print reading/ GD&T
Metrology
Problem solving and 8D
Scheduling work to achieve goals
Customer-focused environment
PC Literacy, windows operations system, Microsoft office (work, excel, outlook, PowerPoint)
Must be able to read and interpret engineering drawings, ANSI-Y-14.5 dimensioning and tolerancing
Knowledge of ANSI-Z1.4 and 1.9 lot sampling
EXPERIENCE AND EDUCATION PREFERRED
Medical, Aerospace or defense experience is preferred
AS9100D, ISO 13485, CAPA, Validations and customer interaction experience preferred.
ASQ CQE Certification preferred
Six Sigma Green Belt Certification preferred
PHYSICAL DEMANDS/WORK ENVIRONMENT
While performing the duties of this job, the employee could be required to stand. 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.
Tecomet, Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, gender identity, religion, sexual orientation, national origin, disability, genetic information, pregnancy, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
