Requirements

• Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
• Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
• Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
• Lead the resolution of quality issues related to non-conformance reports and CAPAs
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Provide QE support to production, purchasing and engineering
• Support/lead test method validation activities
• Conduct and support the development and validation of appropriate test methods for product and process performance
• Develop and initiate sampling procedures and statistical process control methods
• Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
• Address systemic quality issues with suppliers or internal groups
• Oversee calibration and preventive maintenance program
• Assist in the review of lot history records and disposition of product (subassembly and finished goods)
• Work with engineering to develop adequate inspection criteria
• Perform statistical analysis such as capability, gage R&R, and statistical process control
• Evaluate product changes for qualification and validation requirements and assist in change implementations
• Other duties/ activities may be necessary to support departmental or company goals

Education and Job Experience

• A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device,) is required
• BS degree in Engineering is required
• Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
• Experience with non-conformances, CAPA, and Risk Management is required
• Experience in performing test method validation and Gage R&Rs
• Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
• CQE, CQA preferred

Skills and Specifications

• Ability to motivate and influence people
• Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
• Ability to create and provide training
• Good statistical and numerical ability

MUST HAVE:

7 years quality assurance/engineering experience.

Medical Device Industry.

BS Degree in Engineering.

Experience with Non-conformances, CAPA, and Risk Management.

Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971).

Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)

NICE TO HAVE:

CQE, CQA.

Experience in performing test method validation and Gage R&Rs.