Quality Assurance Engineer II Job at Katalyst Healthcares & Life Sciences, Skaneateles, NY

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  • Katalyst Healthcares & Life Sciences
  • Skaneateles, NY

Job 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.

Job Tags

Contract work, Immediate start,

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