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Quality Assurance Engineer
2 months ago
Position Summary:
The Quality Engineer will collaborate with colleagues to ensure adherence to both internal and external customer standards. This role is integral to Tecomet's commitment to continuous enhancement, innovation driven by customer needs, and a culture that prioritizes success while achieving financial and operational objectives.
Key Responsibilities:
- Maintain relevant quality systems, environmental standards, and FDA certifications.
- Facilitate a quality program owned by operators.
- Collaborate with team members to address quality, cost, and scheduling challenges in manufacturing and operations.
- Prepare Failure Mode and Effects Analyses (FMEAs), control plans, quality plans, and Production Part Approval Process (PPAP) documentation.
- Coordinate process validations and minimize reliance on inspection methods.
- Generate quality metric reports, including cost of quality and management by facts.
- Support Material Review Board (MRB) and Return Merchandise Authorization (RMA) processes.
- Investigate customer complaints and implement corrective actions, including CAPA and deviations.
- Engage in special projects as directed by the Director of Quality.
- Demonstrate knowledge of standard manufacturing practices, FDA and ISO regulations, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
- Exhibit proficiency in Geometric Dimensioning & Tolerancing (GD&T) and blueprint interpretation.
- Collaborate with Engineering to design and develop gauging systems, applying basic statistical methods and Six Sigma principles.
- Establish inspection methodologies, participate in MRB meetings, and implement corrective actions for both internal and external processes.
- Engage with internal and external customers and participate in audit processes.
Qualifications:
Educational Background:
- Bachelor's Degree in Quality or a related discipline, or a combination of education, certifications, and experience.
Experience:
- A minimum of 2 years in quality assurance within the medical device manufacturing sector is preferred.
- Experience with ISO 13485, CAPA, validations, and customer relations is preferred.
Certifications:
- ASQ Certification is preferred.
- Professional Engineer (PE) certification.
- Six Sigma Black Belt certification is preferred.
Skills and Competencies:
- Metrology expertise.
- Proficiency in Blueprint and GD&T.
- Understanding of Manufacturing Operations.
- Knowledge of FDA and ISO Regulations.
Additional Requirements:
Mental Requirements:
The work environment reflects typical conditions found in similar roles across comparable organizations.
Physical Requirements:
While performing the duties of this position, the employee may be required to stand, walk, use hands for handling or feeling, reach with hands and arms, and communicate verbally. The employee may also need to sit, climb, balance, stoop, kneel, crouch, or crawl. Occasionally, the employee may lift or move up to 50 pounds. Specific vision abilities required for this role include close vision, distance vision, peripheral vision, and the ability to adjust focus.
Compliance Statement:
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Equal Opportunity Employer:
Tecomet, Inc. is an Equal Opportunity/Affirmative Action Employer, committed to providing a drug-free workplace.
The information provided herein is intended to describe the general nature and level of work performed by employees in this role and is not an exhaustive list of all responsibilities, duties, and skills required. This does not establish a contract for employment and is subject to change at the discretion of the company.
