Planet Pharma · 3 hours ago
Quality Engineer
Irvine, CA
Contract
Onsite
Senior Level
$58/hr - $62/hr
6+ years expPlanet Pharma is dedicated to putting patients first and investing in groundbreaking medical innovations. The Quality Engineer will be responsible for developing and improving quality assurance processes, managing projects, and leading cross-functional teams to enhance manufacturing processes and ensure compliance with industry regulations.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Katarina Cruz
Responsibilities
Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations
Manage cross-functional projects, timelines, and budgets; implement digital quality tools (eQMS, dashboards)
Translate technical information to all levels of the organization through large and small presentations
Independently lead QMS improvement activities and associated projects
Own and perform documentation changes and set policies and standards that are followed by others
Lead CAPA execution, root cause investigations, and quality data analysis to identify trends
Own and drive validation testing (all types), TMV, and software validation testing
Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement
Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk
Drive development and manage execution of complex experiments and tests (including writing and executing protocols) to validate and improve products and establish robust manufacturing processes; ensure completion of process validations (IQ/OQ/PQ), analyze results, and develop reports
Qualification
Required
Bachelors or masters degree in engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences)
6 years of experience in medical device engineering or medical device quality roles
Travel required ~15%
Statistical based software (Minitab, JMP)
Preferred
Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
Certified Quality Engineer (CQE) or equivalent
Measurement and Test Equipment knowledge and experience are essential
Process Validation experience
Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge)
Proficiency in quality tools (FMEA, CAPA, statistical analysis)
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