Job Summary:

The Senior Quality Engineer will interact with team members to ensure compliance and internal and external customer requirements are met. Will work with Key customer representative. Will utilize knowledge of GDNT to interpret drawings and to create inspection plans. 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.

Essential Duties and Responsibilities:

Maintaining applicable quality system, environmental, and FDA requirements/certifications.
Facilitate operator owned quality program
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.
Supporting the MRB and RMA processes.
Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
Special projects as assigned by the Director of Quality.
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.
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.

Qualification Requirements

Educational/Training Requirement:

Bachelor's Degree in Quality or related field and/or a combination of education, certifications and experience will be considered.

Experience:

2 years’ experience in quality within medical device manufacturing industry preferred.
ISO 13485, CAPA, Validations and customer interaction experience preferred.
Thorough knowledge of GDNT
Demonstrated experience creating inspection plans

Licenses/Certifications:

ASQ Certification Preferred
PE certification
Six Sigma Black belt certification, preferred

Knowledge, Skills, and Abilities:

Metrology
Blue Print / GD&T
Manufacturing Operations
FDA / ISO Regulations

Other Requirements

Mental Requirements:

The work environment is representative and typical of similar jobs in comparable organizations.

Physical Requirements:

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.

Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

Americans with Disabilities

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.

8AM to 4H30PM