Overview
Quality Engineer (#ZR Jobs in New York, New York, USA at ZipRecruiter
Position: Quality Engineer (#ZR)
Location: New York
Job Title: Quality Engineer
Location: Rochester, MA, US (must be local)
Reports To: Quality Operations Manager
Salary Range: $90,000 to $110,000
Perks: Generous Bonus, Excellent Benefits, and 401(k)
Job Summary:
A leading manufacturer of disposable medical products is seeking a Quality Engineer to support its Quality Management System (QMS) and ensure compliance with regulatory and procedural requirements. This position plays a key role within the Value Stream Business Unit, assisting in the implementation and oversight of quality programs to ensure process and product compliance under ISO and FDA regulations.
Key Responsibilities:
Ensure compliance with ISO 13485:2016, 21 CFR Part 820, MDD, and internal Quality System requirements.
Serve as the primary quality interface for assigned customers and suppliers.
Monitor customer complaints and trends; conduct failure investigations and recommend corrective actions.
Provide quality support on existing products/processes, including NCMRs, MRBs, root cause analysis, deviations, test procedures, and protocols.
Conduct product and process risk analysis per ISO 14971.
Create Quality Plans and Master Validation Plans for new product implementation.
Develop and execute validation and verification protocols for cleanroom production.
Manage customer quality documentation through the release process.
Present key performance metrics during customer business reviews.
Support Notified Body and customer audits; participate in supplier audits as needed.
Investigate and resolve internal, customer, and supplier quality issues.
Collaborate with Engineering and Manufacturing to establish product and process controls.
Lead root cause failure analysis efforts for products, processes, and components.
Drive corrective and preventive actions (CAPAs) to completion.
Evaluate and approve changes to the Quality Management System, validations, and deviations.
Required Skills and Qualifications:
Deep knowledge of ISO 13485:2016 and FDA QSR under 21 CFR Part 820.
Familiarity with EEC Medical Device Directives and applicable product standards.
Proficient in ISO 14971 risk and hazard assessment.
Strong statistical analysis skills;
Minitab proficiency required.
Skilled in root cause analysis tools (e.g., Fishbone Diagrams, Fault Tree Analysis).
Excellent written and verbal communication skills.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Visio).
Strong presentation and training capabilities.
Education and Experience Requirements:
BS in Engineering, Biology, or a related scientific field.
Minimum of 4 years experience in medical device manufacturing as a Quality Engineer.
Certifications:
Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA).
#J-18808-Ljbffr
Title: Quality Engineer (#ZR
Company: ZipRecruiter
Location: New York, New York, USA
Category: Quality Assurance – QA/QC (Quality Engineering), Engineering (Quality Engineering, Process Engineer)
