
Senior Quality Engineer
- Franklin Lakes, NJ
- $175,900 per year
- Permanent
- Full-time
The Senior Quality Engineer will be responsible for all aspects of the product development process related to ensuring compliance with quality standards and regulations.ResponsibilitiesDevelop and implement quality plans, protocols, procedures, and guidelines for new or existing productsPerform inspections, tests, and analyses on products at various stages in the production cyclePrepare reports summarizing findings and recommendationsMaintain documentation related to product development activitiesCollaborate with cross-functional teams throughout the organizationMonitor product performance during clinical studies or other evaluationsConduct investigations into product defects or customer complaintsEnsure compliance with relevant laws, regulations, and industry standardsStay up-to-date on advances in technology related to medical device manufacturing processesProvide guidance on quality issues encountered during product development projectsSkillsKnowledge of ISO 14971 standard for Medical Device Risk ManagementFamiliarity with Good Manufacturing Practices (GMP) and Design Controls processesKnowledge of regulatory requirementsAbility to read drawings and specificationsStrong understanding of product development lifecycle phasesProficiency in Microsoft Office suite including Word, Excel, PowerPoint, and ProjectExcellent verbal and written communication skillsRequired QualificationsBachelor’s degree in Engineering, Life Sciences, or equivalent field required and 5 years experienceMaster's Degree in Engineering, Life Sciences, or equivalent field required and 2 years experienceExperience in manufacturingPreferred Qualifications:
- Experience conducting investigations into product defects/customer complaints
- Experience in medical device industry