Quality Engineer Medical Devices

Job Summary:

Seeking an experienced Quality Engineer to provide Quality oversight for equipment validation and qualification activities in a medical device environment. This role focuses on protocol authoring and review, validation documentation approval, deviation investigations, and compliance with applicable quality system requirements.

Key Responsibilities:

• Write, review, and approve equipment validation and qualification protocols.

• Review test results, supporting records, and final reports for accuracy, completeness, and compliance.

• Investigate and document deviations associated with validation and qualification activities.

• Partner with Engineering, Validation, Manufacturing, and Quality teams to resolve documentation gaps and compliance issues.

• Maintain controlled quality records according to approved procedures.

• Support audit readiness and ensure validation activities meet established quality standards.

Required Qualifications:

• Experience in the medical device industry.

• Equipment validation and qualification experience from a Quality Assurance or Quality Engineering perspective.

• Hands-on experience writing and reviewing validation protocols and reports.

• Experience documenting and investigating deviations.

• Strong understanding of medical device quality systems, regulatory compliance, and documentation practices.

• Excellent technical writing, attention to detail, and cross-functional communication skills.

Preferred Qualifications:

• Experience with IQ/OQ/PQ or process validation.

• Familiarity with applicable FDA 21 CFR Part 820 and ISO 13485 requirements.

• Experience supporting regulated manufacturing operations.
  

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

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