Manufacturing Quality Engineer - Medical Device

Title: Manufacturing Quality Engineer

Reports to: Director, Quality Assurance

Location: Andover, MA

Salary: $100-120k + bonus

ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO:

• Provide Quality Engineering support in the manufacturing of Medical Devices & hardware.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
• Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Support the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.
• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
• Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.

BACKGROUND AND QUALIFICATIONS:

• Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role

• Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
• Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
• Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
• Experience with handling non-conforming material and assemblies.
• Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired.
• Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools
• Ability to communicate ideas and information clearly, effectively, and concisely.

EDUCATION:

• BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.