Job Description

MUST:

• 2+ years of experience in Quality engineering in a production facility
• Bachelors degree in mechanical engineering or biomedical engineering
• Corrective action and improvement plans within quality + Corrective and Preventive Action (CAPA)

PLUS:

• Six Sigma Certification Green, Brown or Black belt preferred.
• ASQ CQE preferred.
• Medical Device

DAY TO DAY:

The Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits.

• Contributes to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria, and statistical principles. Assists in writing and reviewing protocols, reports, and operating procedures to support product and process development.
• Supervises and performs risk management activities including creation and maintenance of risk management files by product and process as the key quality representative for those tasks.
• Support design control new product introduction teams as the quality subject matter expert and provide review and approval of product Design History Files.
• Act as the leader in bringing the culture of quality in medical device development.
• Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures.
• Collaborate with and guide cross-functional team members and stakeholders to ensure correct and efficient implementation of Design Controls and Quality System procedures.
• Active participant in assigned Design and Phase Review meetings.
• Drives improvements to the QMS including those resulting from quality events, audits, or regulatory changes to ensure compliance with FDA 21 CFR 820.
• Assisting in the development of the company quality system to support medical device offerings and operations and ensure continual improvement in quality. This may include drafting and reviewing quality system documents as necessary, managing document change requests, and regularly reviewing procedures for appropriateness.
• Assisting with quality system implementation
• Maintaining and documenting supplier approvals and audits as needed.
• Participating in internal audits and serving as subject matter expert during regulatory inspections and notified body audits.
• Assisting with and documenting regular management reviews.
• Drafting and executing IQs, OQs, and PQs, where applicable.
• Initiating, investigating, and reviewing non-conformances as well as corrective and preventative actions, as assigned.
• Assisting in product failure and root cause investigations.
• Generally assuring adherence to all company quality procedures

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