Quality Engineer
Dutch Ophthalmic USA
full-time
Posted on:
Location Type: Office
Location: Exeter • New Hampshire • United States
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Tech Stack
About the role
- Identify and assist with process validation activities.
- Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
- Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
- Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
- Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
- Inspect product including labeling and documentation for release of finished goods.
- Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs
- Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
- Oversee creation and review of documentation for nonconforming products.
- Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
- Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed
- Keep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.
- Assist with revisions and updates to quality procedures, standardized work instructions
- Participate in supplier management activities. Identify supplier quality issues and report to management in timely manner.
- Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).
Requirements
- Must have a four-year engineering degree.
- Bachelor’s or Master’s Degree in a technical area.
- 5–10 years related experience.
- Minimum of 4 years of work experience in a Quality Engineering role within a manufacturing environment in the Medical Device preferred.
- ISO 13485 and GMP Experience.
- High proficiency in computer technology and systems operations.
- Strong knowledge of Microsoft Office applications.
- Strong analytical and problem-solving skills.
- Auto CAD, Solid Works, ERP experience is a plus.
- Experience working under a microscope is a plus.
Benefits
- Medical – 90% employer paid
- Dental – 100% employer paid
- Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
- Vision
- 401k Matching
- Paid Leave: Sick, Vacation and Holidays
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process validationquality controlrisk managementPFMEAnonconformance investigationCAPAmanufacturing proceduressupplier quality managementanalytical skillsproblem-solving
Soft Skills
project managementcommunicationleadershiptrainingdocumentation reviewteam collaborationattention to detailtime managementadaptabilitycritical thinking
Certifications
Bachelor's DegreeMaster's DegreeISO 13485 certification