Basic Information

Job Category: Quality Control - QA

Location: Plainview, NY, New York, United States

Date published: 27-May-2022

Job type: Full Time

Description and Requirements

About the role

Schivo Medical is currently seeking a Quality Assurance Manager to join our team in the Long Island, NY region.

About the Role:

·         The Quality Assurance (QA) Manager will oversee the activities of the quality assurance department and staff. QA Manager will be responsible for developing, implementing, maintaining Quality Management systems standard to ISO-13485 and reliability testing for the organization’s products and/or development processes.

What You’ll Do:

  • ·         Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
  • ·         Serve as Management representative during ISO 13485, FDA, and customer audits
  • ·         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 the 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
  • ·         Hires and trains quality assurance staff
  • ·         Conducts performance evaluations that are timely and constructive
  • ·         Handles discipline and termination of employees in accordance with company policy
  • ·         Other duties/ activities may be necessary to support departmental or company goals

Our Ideal Candidate:

Education and Experience

  • ·         Minimum 5 years of quality assurance/engineering experience is required.
  • ·         Experience in a regulated industry (medical device,) is preferred.
  • ·         Bachelor’s degree in Engineering is preferred
  • ·         Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 or AS9000) is required
  • ·         Experience with non-conformances, CAPA, and Risk Management is required
  • ·         Experience in performing test method validation and Gage R&Rs
  • ·         Extensive experience in root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)

Required Skills and Abilities

·         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 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

What We Offer:

  •          Competitive pay; commensurate with experience