Quality Engineer III (Healthcare)
POSITION SUMMARY:
- This position is accountable for development, implementation, evaluation, and support of quality system activities for their assigned plant.
- Manage specific aspects of the quality and product safety management systems including internal audit, calibration, nonconforming material control, inspection and test method validations, and others as assigned by the Quality Manager
- Prepare appropriate quality-related reports as assigned by the Plant Quality Manager.
- Represent the company in a professional manner when interacting with suppliers, customers, and internal stakeholders.
ESSENTIAL DUTIES:
- Manage internal audit program, including development of annual audit schedules, conducting audits, and assigning auditors, evaluating, and tracking audit reports and findings, initiating and following up on corrective actions.
- Ensures regulatory requirements like 21 CFR Part 820, MDSAP, and ISO 13485, are met.
- Participate in new product qualifications and validations to ensure quality, product safety and regulatory requirements are addressed pre-production.
- Participate in customer complaint and NCR investigations and other problem-solving efforts. Assist in measuring/collecting products and process data/information necessary to determine or validate root causes and permanent corrective actions.
- Technical lead for inspections which includes defining methods and qualifying the method (TMV, Gage R&R)
- Manage Environmental Monitoring process including both viable and non-viable monitoring
- Manage outsourced sterilization process including supplier management, load release documentation and review of results.
- Programming optical/vision-based measurement systems like MicroVu, Keyence etc.
- Lead process automations like paperwork reduction, Quality 4.0 initiatives, Electronic QMS implementation.
- Utilizing lean and six sigma tools to reduce COPQ, improve internal manufacturing and non-manufacturing processes.
- Defines and implements quality system processes and procedures.
- Understands all aspects of assigned production line(s) to help minimize scrap and complaints.
- Implement corrective actions and use CAPA system to consistently improve product quality.
- Prepares written protocols and reports.
- Performs a variety of complex tasks using experience and judgment.
- Mentor junior level team members.
- May lead and direct the work of others in various projects and assignments.
- Upholds SPG and Dupont vision and core values.
- Performs other duties as required.
QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required:
- Bachelor's degree or higher in Engineering (Mechanical/Industrial/Engineering Management/Biomedical/Electrical)
- 7 + years of industry experience in a similar role
- Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs.
- Ability to problem solve, identify errors and deficiencies and perform research independently
- Ability to apply knowledge to their job function using pre-established guidelines and instructions
- Accuracy, attention to detail, and thoroughness
- Proficient in computer skills and ability to use MS office, Minitab or the statistical tools.
- Proficient communications skills
- A wide degree of creativity and latitude
- Ability to comprehend and comply with company safety and quality standards
- Ability to follow oral and written instructions
- Responsible for understanding and complying with all SPG and Dupont safety policies and procedures.
Preferred:
- Previous experience in Quality Assurance
- Prior experience in environmental monitoring and sterilization process management
- Knowledge in Statistics and SPC
- Medical device experience
- Certified Quality Engineer (CQE)
- Lean Six Sigma Green Belt or Black Belt
WORKING CONDITIONS:
This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.
