Quality Assurance Engineer II

Job Description

Job DescriptionCompany Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description:

We are seeking a Systems or Quality Engineer to be responsible for integrating design procedures, templates, and guidance documents within our ISO 13485 compliant Quality Management System (QMS). The successful candidate will have a working knowledge of FDA/ISO regulations, specifically ISO 13485 (7.3) and 21 CFR 820.30, and the application of Good Documentation Practices. Demonstrate ability in writing quality system procedures. The ideal candidate will have a demonstrated ability to communicate with a wide range of stakeholders, including Quality, Systems/Risk, Project Management, Regulatory Affairs, Marketing, and others.

Responsibilities:

• Complete SOP gap assessments for process integration focused on the Front-Line Care division.
• Participate in 'deep dive' reviews of selected procedures with Subject Matter Experts (SMEs). Ensure that process details driven by prior corrective actions are reviewed and maintained as appropriate.
• Write/update, review, analyse, and revise Standard Operating Procedures (SOPs), work instructions, forms, templates.
• Drive reviews/approvals of SOPs with cross functional Subject Matter Experts (SME’s).
• Monitor actions for proper SOP implementation.
• Report periodic integration status to stakeholders.
• Work with different functional groups and produce appropriate documentation in support of SOP integration.
• Strong verbal and written communication skills, documentation practices, be self-motivated and possess strong interpersonal skills.
• Excellent problem-solving skills and attention to detail.

Requirements:

• Is a bachelor’s degree Required? YES.
• How many years of recent experience does this person need to have? 2-4.
• Medical Device experience.
• Knowledge of ISO 13483 and 21 CFR 820.30.
• Experience writing Standard operating procedures (SOP’s).
• Strong writing and communication skills.
• Knowledge of Agile Product Lifecycle Management Tool.
• Knowledge of SAP Tool.
  

Additional Information

All your information will be kept confidential according to EEO guidelines.