Description:
Manufacturing Quality Engineer
• Location: Skaneateles, NY
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Length: Until 1/2026 (Contract extension expectation)
• Pay Rate - $45 - $51 hourly depending on experience
• Work Authorization - Must be able to work in the U.S. with approved authorization status.
What You'll Do:
- 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, analyze, 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.
Qualifications
- Medical Device experience
- Knowledge of ISO 13483 and 21 CFR 820.30
- Experience writing Standard operating procedures (SOP’s)
- Strong writing and communication skills