Quality Engineer II

Tecomet, Inc•Riviera Beach, FL

About The Position

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.

Requirements

Bachelor’s Degree in Engineer or related field. Or a minimum of 6 years’ experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE)
Use standard office equipment which may include computers, phones, photocopiers, filing cabinets and fax machines.
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.

Nice To Haves

ASQ CQE or CMQ/QE preferred
2 years’ experience in quality within medical device manufacturing industry preferred
ISO 13485, FDA 820 and customer interaction experience preferred

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.