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. Principle 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. Qualification Requirements Credentials/Experience: - 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) Experience/Educational/Training Preferred: - 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 Knowledge, Skills, and Abilities: - 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. Other Requirements Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Requirements 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. Travel Requirements Up to 10% Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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.