ESSENTIAL FUNCTIONS:

• Develop and maintain quality assurance plans for responsible area.
• Maintain departmental quality documentation and records.
• Knowledgeable of requirements and champions system audits including but not limited to ISO, USP Class VI, FDA/GMP, customer, internal and third party. Ensure conformance to involved standards.
• Leads efforts to resolve customer complaints and product returns via defect analysis, root cause identification and implementation of irreversible corrective actions.
• Supervision of Quality Control Technicians including daily direction and support, training, time keeping and attendance, overtime offers and coordination, and vacation scheduling.
• Identify and procure gages.
• Leads gage calibration program, conduct gage R&Rs and is knowledgeable on measurement systems analyses in general.
• Proficient in the measurement of parts and tooling via industry accepted measurement devices and systems including, but not limited to, micrometers, verniers, and calipers, coordinate measurement machines and comparators.
• Proficient in generating customer specified certification packages including inspections and other requirements.
• Perform tool certifications/verifications.
• Interface with supply chain personnel to resolve purchased material quality issues. Issue formal supplier non-conformance reports and follow-up to verify robust corrective actions.
• Ensure new product launches conform to customer and company requirements.
• Contact/visit customers and suppliers.
• Participate in supplier qualifications and part approval activities. Assist in conducting supplier audits.
• Understand and communicate customer requirements. Assist with customer contract reviews from a quality conformance perspective.
• Understand special processes and how to verify that special processes are under control.
• Train employees on all aspects of the quality system.

COMPETENCIES:

JOB QUALIFICATIONS:

• Four-year degree in an engineering discipline or equivalent
• Five years minimum experience in quality, pharmaceutical experience a plus
• Formal audit training and CQA desirable
• Experience in ISO 9001
• Proficient computer skills
• Multitask oriented
• Organizational skills
• Communication skills
• Ability to travel (approximately 5% – 15%)

WORKING CONDITIONS: Office and Warehouse Environment

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Rubber Fab values diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require accommodation due to a disability at any time during the recruitment and/or assessment process, please contact Talent Acquisition and we will make all reasonable efforts to accommodate your request.