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Quality Assurance Specialist
2 months ago
Phaidon International is seeking multiple Quality Assurance Engineers to enhance our Quality department. The selected Quality Engineers will deliver practical assistance to guarantee that all responsibilities and tasks are executed effectively. Below are the key responsibilities and qualifications:
Position Title: Quality Assurance Engineer
Role Overview:
Work Arrangement: Remote
Contract Duration: Minimum of 6-12 months
Key Responsibilities:
- Manage Non-Conforming Material Reports (NCMR) which includes conducting root cause analysis, risk evaluations, historical data assessments, and developing corrective action strategies.
- Oversee Complaints Reviews and Manufacturing Analysis, focusing on event evaluations, root cause investigations, risk assessments, and historical record analysis.
- Lead Corrective Action Preventive (CAPA) processes, including root cause analysis, scope definition, resolution planning, execution, and effectiveness verification.
- Address regulatory inquiries, ensuring compliance certification and product-related queries are handled efficiently.
- Support Manufacturing and Production Lines by collaborating with operational teams to meet value stream objectives.
- Facilitate Change Control by managing documentation change orders in accordance with quality system protocols.
- Conduct Validation and Qualification processes, including Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), and Master Validation Plan/Report.
- Manage Deviations by performing risk assessments and establishing closure criteria.
- Implement Risk Management strategies by utilizing and interpreting Hazard Analysis and updating Failure Modes and Effects Analysis.
Required Skills and Qualifications:
- Bachelor's Degree in a relevant field.
- A minimum of 2 years of experience in Quality Assurance, specifically in complaint processing.
- Prior experience in the medical device sector with knowledge of ISO 13485, FDA 21 CFR 820, and European Union MDD/MDR regulations.
- Ability to conduct complaint investigations with minimal supervision.
- Strong analytical and problem-solving skills, with a proven track record of resolving complex issues.
- Familiarity with technical writing principles.
- Experience in investigating firmware/hardware-related complaints is advantageous.
- Meticulous attention to detail and adherence to timelines are essential.
- Exceptional verbal and written communication skills, along with strong interpersonal abilities.
- Proficient in MS Word, Excel, Adobe Acrobat, and other standard software applications.
- Basic understanding of Quality Systems (CAPA/non-conformances/SCARS) is a plus.
- Ability to work independently and collaboratively within a team environment.
- A positive and proactive team player.
