What are the responsibilities and job description for the Quality Engineer II position at Tecomet, Inc.?

Job Description

JOB TITLE : Quality Engineer II

REPORTS TO :

Will be populated by each location. Font used is Bold Calibri 12; Color Black; upper and lower case

DEPARTMENT NAME :

Will be populated by each location. Font used is Bold Calibri 12; Color Black; upper and lower case Font used is Bold Calibri 12; Color Black; upper and lower case

FLSA STATUS (U.S.Classification) :

Exempt

POSITION SUMMARY :

The Quality Engineer II will interact with team members to ensure compliance and internal and external customer requirements are met. 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;
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 as assigned by quality management;
Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations;
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements;
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;

KNOWLEDGE and SKILLS :

Manufacturing operations – forging and / or machining;

Measuring devices;

Quality Systems;

Regulations – FDA, GMP and ISO;

Blueprint reading;

Metrology;

Problem solving and 8D;

Math skills (algebra, trigonometry) skills;

Microsoft office (Word, Excel, Outlook, PowerPoint);

Minitab;

EDUCATION and EXPERIENCE :

Bachelor's Degree in Engineering or related field.

OR without a degree, a minimum of 6 years’ experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ / OE);

ASQ CQE or CMQ / OE preferred;

2 years’ experience in quality within medical device manufacturing industry preferred;

ISO 13485, FDA 820 and customer interaction experience preferred;

WORK ENVIRONMENT / PHYSICAL DEMANDS :

Use standard office equipment which may include computers, phones, photocopiers, filing cabinets and fax machines;

Well lighted, heated / or air-conditioned indoor office / production setting with adequate ventilation;

Production floor could be frequently exposed to fumes or airborne particles, moving mechanical parts and vibration, and moderate to loud noise conditions;

Ability to meet safety, regulatory and health guidelines without assistance;

Ability to maneuver throughout the facility / facilities as needed;

Ability to wear proper Personal Protective Equipment (PPE);

Ability to perform repetitive work;

Standing; walking; manual dexterity sufficient to reach / handle items and work with fingers;

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus;

Travel at times may be required;

Employee Signature : ____________________________________________Date : ______________

SPECIAL POSITION REQUIREMENTS

The duties, responsibilities, and requirements in this job description should never be considered to be all inclusive.

In accordance with Americans with Disabilities Act, it is possible that the essential functions of this job may be modified to reasonably accommodate disabled individuals.

Tecomet, US is an at-will employer and reserves the right to terminate any employee for any reason not prohibited by law.

Tecomet is an Equal Opportunity Employer M / W / Vet / Disabled.

Manager / Team Lead : ____________________________________________Date : ______________

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