Quality Engineer

Actalent • San Clemente, CA

30d • $130,000 - $160,000 • Onsite

About The Position

We are seeking a advanced-level Quality Engineer with a strong pharmaceutical experience to join our team in support of a drug-eluting temporary stent program. This role will focus on in-house manufacturing, drug coating processes, equipment validation, and regulatory submissions in accordance with ICH and other relevant standards.

Requirements

• Bachelor's degree (or higher) in engineering, chemistry, or a related field.
• Advanced-level experience in pharmaceutical or medical device quality engineering.
• Hands-on experience with equipment validation (IQ, OQ, PQ).
• Familiarity with drug coating processes and analytical chemistry techniques.
• Strong understanding of quality systems, GMP/GLP, and data integrity.
• 4+ years of experience in pharmaceutical manufacturing.
• Advanced experience in equipment validation.
• Knowledge of drug coating processes, engineering, validation, reliability engineering, failure analysis, report writing, regulatory submission, quality assurance, and quality engineering.

Nice To Haves

• Proficient in laboratory software and data systems.
• Excellent problem-solving, organizational, and communication skills.
• Hands-on experience with regulatory submissions (ICH, FDA).

Responsibilities

• Lead quality engineering activities for the development and manufacturing of drug-eluting stents.
• Oversee drug coating processes, ensuring compliance with GMP, GLP, and ICH guidelines.
• Manage equipment validation protocols (IQ, OQ, PQ) and support qualification activities.
• Collaborate with R&D and manufacturing teams to optimize processes and ensure product quality.
• Assist in preparing regulatory submissions and documentation for FDA and international agencies.
• Support risk assessments, CAPAs, and root cause investigations related to product and process quality.
• Maintain and improve quality systems, documentation practices, and data integrity.
• Provide technical expertise in analytical methods and troubleshooting.
• Utilize laboratory software and data systems (e.g., LIMS, Chromeleon) to support quality operations.

Benefits

• Medical, Dental, Vision paid 100% by employer
• Employee stock options

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Number of Employees: 1,001-5,000 employees