Quality Engineer: ISO 13485 & FDA Medical Devices

FELIX STORCH INC; New York (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical/Dental

Vision insurance

Transit benefits

401k with company match

Paid vacation

Discretionary bonuses

Job summary

Felix Storch Inc. is seeking a Quality Engineer to implement ISO13485 and FDA certification for medical devices. The role leads quality programs across facilities, partnering with senior management to grow manufacturing, sourcing, and operations while upholding quality standards.

The position is full-time, on-site, based in Bronx, NY or Edison, NJ, with occasional travel. Ideal candidate will have FDA Class II device QA experience, ISO 9001 knowledge, and strong data analytics capabilities.

Qualifications

• 4 Year degree in Engineering, Statistics, Mathematics, or Project Management.
• Minimum of 5 Years of Experience in Leading Quality and Project Management activities
• Minimum of 2 years of experience in Quality management of FDA Class II Devises, ISO 13045 or related fields
• ISO 9001 Lead Auditor Certification (Preferred)
• Strong technical background with Product Quality and Project Management with extensive experience in leading processes and teams
• Advanced knowledge/experience in Data Analytics.
• Ability to lead cross-functional teams.
• Able to take initiative and work interdependently, and collaborate with teams

Responsibilities

• Implement ISO13485 quality program and FDA certification for medical devices
• Maintain and help upgrade our ISO/IEC 9001: 2015 to the upcoming standard.
• Develop, review and maintain our quality manual, policies, objectives, procedures, work instructions and forms required to comply with ISO 9001:2015 and FDA requirements for Class II medical devices.
• Prepare for external audits and manage communication with third party certifying agencies and FDA during audits, inspections and investigations.
• Maintain all records of the Quality Management System and ensure they are accurate for external audits.
• Develop and maintain internal audit programs to proactively identify compliance issues or relevant changes to the QMS
• Review internal QC processes and coordinate with internal departments to ensure adherence to ISO requirements.
• Interface with Product Development, Engineering, Purchasing, and Logistics organizations to provide expert quality guidance.
• Work with our sourcing team to drive supplier quality performance.
• Support Operations facilities during customer and third-party audits and develop corrective actions as necessary.
• Create a positive working environment that encourages creative thinking and drives engagement.
• Other related duties as assigned

Skills

Quality leadership

Data analytics

Cross-functional leadership

Team collaboration

Education

Engineering/Statistics/Mathematics/PM degree

ISO 9001 Lead Auditor Certification

Job description

Felix Storch Inc. is seeking a Quality Engineer to implement ISO13485 and FDA certification for medical devices. The role leads quality programs across facilities, partnering with senior management to grow manufacturing, sourcing, and operations while upholding quality standards.

The position is full-time, on-site, based in Bronx, NY or Edison, NJ, with occasional travel. Ideal candidate will have FDA Class II device QA experience, ISO 9001 knowledge, and strong data analytics capabilities.