Analyst

Applied Medical•Rancho Santa Margarita, CA

About The Position

Applied Medical is a medical device company that develops and manufactures surgical technologies. The Analyst supports and coordinates bioburden, sterility, and other biological testing programs related to medical device manufacturing. Within the Biological Sciences function, the role maintains laboratory records, reviews and analyzes testing data, and supports compliance with applicable regulations, industry standards, and internal quality system requirements. Under guidance from senior team members, the position is predominantly quality-focused, with involvement in laboratory testing activities to support operational needs. The Analyst maintains awareness of evolving regulations and standards and provides analytical, technical, and operational support to internal stakeholders, customers, regulatory agencies, and suppliers. Success involves delivering audit-ready records, coordinating testing programs and schedules, identifying trends and potential investigations, improving laboratory workflows, maintaining compliance, and communicating technical findings clearly.

Requirements

Work effectively independently and within a collaborative, cross-functional team.
Apply strong analytical, problem-solving, and critical-thinking skills, with exceptional attention to detail and accuracy.
Analyze data, identify trends, and support continuous improvement initiatives.
Demonstrate initiative and sound judgment, ask questions, challenge assumptions, and seek clarification when appropriate.
Communicate technical information clearly through verbal, written, presentation, and interpersonal skills.
Maintain a customer-focused mindset and professional, collaborative approach.
Organize and manage multiple priorities to meet deadlines in a fast-paced environment.
Adapt to change with accountability and a commitment to quality, compliance, and continuous learning.
Understand laboratory test methods, standard operating procedures (SOPs), and related laboratory practices.
Apply technical knowledge of microbiological techniques and laboratory procedures.

Nice To Haves

Bachelor's degree (BS) in biological sciences, physical sciences, life sciences, or another relevant technical discipline.
Two to three years of relevant professional experience, preferably in medical device, life sciences, pharmaceutical, healthcare, or regulated manufacturing environments.
Experience supporting biological testing, quality, regulatory, or laboratory operations functions.

Responsibilities

Coordinate biological testing activities—including bioburden, sterility, and other programs conducted by external laboratories—and related purchase requisitions and purchase orders for routine quality and R&D initiatives.
Coordinate and monitor quarterly, semi-annual, and other scheduled laboratory audits to ensure timely completion and compliance with established requirements.
Prepare, review, and maintain testing protocols, study plans, technical documentation, and final laboratory reports in accordance with applicable quality and regulatory requirements.
Maintain laboratory data and identify trends and investigation needs related to testing outcomes, deviations, and performance metrics.
Partner with Engineering, Manufacturing, Quality, and other cross-functional teams to coordinate collection, preparation, and shipment of test samples.
Ensure testing activities, documentation, and records comply with applicable regulations, international standards, internal procedures, and quality system requirements.
Participate in cross-functional projects to improve systems, workflows, and operational processes related to Biological Sciences activities.
Maintain testing schedules, track project milestones, and communicate status updates to stakeholders.
Communicate technical findings to internal stakeholders, customers, regulatory agencies, and suppliers.