Senior Quality Engineer

Job Title: Senior Quality Engineer
Location: Greenville, SC
Duration: Full time/Direct Hire
Department: Quality Assurance
Compensation: $80-90k
Reports to: Director of Quality
Industry: Medical Device/Pharma

BASIC FUNCTIONS:
The role of the Senior Quality Engineer is to work with engineering, process, and manufacturing personnel to develop specifications, processes, and procedures that will ensure our products meet or exceed our customers’ expectations.
Organizer on all major components of the QMS including change control, process control, calibration, and CAPA through feedback.
Continuous improvement should be an output from the constant QMS PDCA feedback loop.

EDUCATION/EXPERIENCE:
• Bachelor’s degree in an engineering, health science or related field preferred.
• 5+ years’ experience as a Quality Engineer in the medical device industry.
• If degree is not in Engineering or a Health Science field, 10+ years of Quality Engineer or Medical Device Regulatory experience required.
• Lead ISO 13485 Auditor certification preferred.

ACCOUNTABILITIES:
• Responsible for supervision of QA Inspectors / Technicians (in-process and outgoing quality). This includes the review of associated records.
• Quality Assurance Inspectors:
• Performs inspections and tests for incoming, in-process, and finished products. Serves as authority for the release of Class II Devices for further distribution. Performs complaint investigations and service on returned products. Maintains records, including files of device history records.
• Administrates the internal audit program and vendor approval.
• Performs routine audits of the preventive maintenance program and other internal audits as assigned.
• Responsible for assisting in the coordination and administration of Engineering Change Orders from engineering to manufacturing for both new products and changes to existing products.
• Assist in ensuring that all activities relative to the engineering change are performed, documented, and records maintained - regulatory requirements, process capability/control, quality plans, etc.
• Responsible for the calibration program
• Set up proper instrumentation to measure and record variables and train employees on the proper use of the instruments.
• Establish Process Control Plans
• Interface with product development, manufacturing, process, and quality personnel as well as with sales and marketing to determine product quality specifications.
• Provide all necessary information concerning product parameters and inspection to production personnel
• Assist in developing effective corrective actions to quality issues
• Assist with returned product investigations as needed to understand failure modes and actions required.
• Assist with handling customer complaints and service requests.
• Assist with various Regulatory Activities:
• Develop regulatory strategies for product development and launch of new products.
• Ensure that US and other international regulatory requirements are incorporated as part of the development process.
• Assist or lead the preparation and maintenance of moderate-complexity regulatory submissions while maintaining quality standards.
• Maintain facility and product registrations and licenses with various regulatory bodies.
• Establish an effective Statistical Process Control Program
• Willing to travel internationally to internal and external customers to resolve quality problems and build effective customer relationships.

TECHNICAL COMPETENCIES:
System Management and/or Maintenance & Development:
• Ability to understand and utilize basic statistical analysis.
• Ability to perform root cause analysis and corrective action.
• Ability to understand and utilize fundamental gauge validation and calibration.
• Demonstrates thorough understanding of auditing systems.
• Demonstrates basic mechanical aptitude ability.
Quality Management Systems:
• Ability to develop and maintain processes that are ISO, MDSAP, and FDA compliant.
• Demonstrates ability to lead and manage projects.
• Ability to train and develop internal auditors.
• Ability to utilize failure mode and effects analysis.
• Ability to identify, execute and measure improvement opportunities.
Safety:
• Demonstrates ability to understand and actively participate in all company safety policies and procedures.
Training:
• Ability to develop, deliver and measure training as required.

PHYSICAL JOB REQUIREMENTS:
Primary environment: ambient room temperatures, lighting and traditional office equipment as found in a typical office environment. The performance of this position may occasionally require exposure to the manufacturing areas where the use of personal protective equipment such as safety glasses with side shields and fully enclosed shoes (no open toe or heel) are required.



We are an equal opportunity employer that recognizes the value of a diverse workforce. All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, or any other criteria protected by governing law.