Planet Pharma · 1 day ago
Engr 3, Quality (Quality Engineer)
Franklin Lakes, NJ
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is a company focused on supporting new product development and product maintenance in the medical device sector. The Quality Engineer will apply Quality Engineering skills to ensure that products meet quality standards and regulatory requirements throughout their lifecycle.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools
Proven problem-solving skills
Makes measurable improvements to processes and procedures
Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
Acts as a team member representing Quality on new product development and sustaining engineering projects
Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc
Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training)
May perform other duties as required
Qualification
Required
Design Controls
FDA Quality System Regulation
Proactive Problem Solving
Process Validation
Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience
Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of products
Applied knowledge of Corporate and/or Unit requirement
Able to contribute to the completion of specific programs and projects
Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers
Able to revise policies and procedures
Able to make presentations
Can independently determine and develop approach to solutions
Able to provide guidance and work direction to lower level project developers
Can design and perform development working independently within defined parameters with minimal supervision required
Preferred
Experience with software systems utilized in the Quality Systems is desirable
Acceptance sampling theory and application
Statistical process control methods and application
Measurement system/test method knowledge and analysis
Quality planning
Failure analysis investigation
Design of Experiments
Process mapping and value stream analysis
Hypothesis testing
Descriptive statistics
Process capability analysis
Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc
Risk Management
Supplier quality management
Auditing
Design/development tools
Process validation
Software validation
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