Planet Pharma · 6 hours ago
Quality Engineer 3 (Medical Device)
Franklin Lakes, NJ
Full-time
Hybrid
Senior Level
$32/hr - $42/hr
5+ years expPlanet Pharma is seeking a Quality Engineer to join their team as a Quality Engineering Core Team Member for a high-priority New Product Development project. The role involves overseeing the end-to-end quality lifecycle, ensuring compliance with regulations, and driving continuous improvement efforts.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Patrick Sazama
Responsibilities
Act as the primary Quality representative on cross-functional teams, overseeing design control aspects, including inputs, outputs, drawings, and test methods
Ensure all projects meet FDA 21 CFR Part 820 and ISO 13485 standards. Lead process and design validations (IQ/OQ/PQ)
Review and provide Quality Engineering approval for new design/process specifications and product performance metrics
Drive risk-related activities, including FMEA, Hazard Analysis, and Risk Management Files
Apply advanced quality tools such as DOE, SPC, and Hypothesis Testing to improve internal processes and procedures
Assist with supplier qualifications and audits to ensure the integrity of the global supply chain
Qualification
Required
Bachelor's Degree (BS) in Engineering, Science, or a related technical discipline
5+ years of relevant experience within the Medical Device industry (other highly regulated industries may be considered)
Expertise in Design Controls and Process Validation
Deep understanding of FDA Quality System Regulations (QSR)
Proficiency in Risk Management (ISO 14971) and Supplier Qualifications
Strong presentation skills with the ability to communicate technical data and project milestones to upper management
Proficiency in SAP (Document Control), Trackwise, and Microsoft Excel is highly desirable
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase