Quality Engineer (Medical) Jobs

3 Must haves on the resume: Risk Management Knowledge, Design controls exposure, Knowledge with Engineering change control processes, targeted knowledge with MDR.

Responsibilities:

• Support modification and maintenance of quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements

• Implement Corporate and Business level Quality System procedures for the design center locations under supervision

• Facilitate internal quality system audits per the procedural requirements

• Support the management of external audits

• Lead or Support the development of content for the management review process

• Update and report on monthly quality metrics

• Provide inputs on revisions to Corporate and Business level procedures as necessary

• Support supplier management efforts for the design center

• Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements

Educational Requirements:

• A minimum of Bachelor’s degree in Science or related discipline

• Certified ISO 9001/13485 Lead auditor is desirable

• Knowledge of Design Control, Risk Management and QMS processes

• Minimum 1-2 years of experience developing and sustaining quality systems of medical devices

Knowledge and Skills:

• Exposed to internal and external audits as an auditor and/ or auditee

• Some knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.)

• Good technical writing, communication skills, and managing small quality system project

• Desirable knowledge with Design Control/ Change control process, CAPA, Deviations and Non-conformances

• Design Control

• EU MOD/MOR

• Change control

• Risk Management

• Process Validation

• Identification of CTQ's

• Handling of deviations and non-conformances

• Test method validations

• CAPA- Root cause investigation and implementation of corrective / preventive actions

• Proper Use of Statistics (Sampling Plans)

• Advise on Regulations and standards

• Liaise with Manufacturing Plants

• Provide functional support to cross-functional teams G Support Internal and external audits

Requirements:

• Bachelor's Degree.

• A minimum of 4+ years of relevant experience or a combination of equivalent education and relevant experience.

• Minimum 2 - 3 years of experience supporting design assurance for medical devices

• Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements.

• Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO