Analyst

Location: Rancho Santa Margarita, California, United States

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

The Analyst supports and coordinates bioburden, sterility, and other biological testing programs tied to medical device manufacturing. Working as a quality analyst within the Biological Sciences function, the microbiology analyst maintains laboratory records, reviews and analyzes testing data, and supports compliance with applicable regulatory requirements, industry standards, and internal quality system expectations. Under the guidance of senior team members, the microbiology analyst works in a predominantly quality-focused role, with involvement in laboratory testing activities to support operational needs.

The role maintains awareness of evolving regulations and standards while providing analytical, technical, and operational support to internal stakeholders, customers, regulatory agencies, and suppliers.

Key Responsibilities

• Coordinate biological testing activities, including bioburden, sterility, and other testing programs conducted by external laboratories, along with related purchase requisitions and purchase orders, in support of routine quality and Research and Development (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 investigations related to testing outcomes, deviations, and performance metrics.
• Partner with Engineering, Manufacturing, Quality, and other cross-functional teams to coordinate the 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 that improve systems, workflows, and operational processes related to Biological Sciences activities.
• Maintain testing schedules, track project milestones, and communicate status updates to stakeholders.

Success in This Role Looks Like

• Deliver accurate, audit-ready laboratory records and testing documentation that hold up under regulatory and quality system review.
• Ensure biological testing programs run on schedule through strong coordination with external laboratories and cross-functional teams.
• Identify testing trends, deviations, and investigation needs early, supporting timely quality decisions.
• Drive continuous improvement in laboratory workflows and operational processes.
• Maintain compliance with evolving regulations, international standards, and internal quality requirements.
• Communicate technical findings clearly to internal stakeholders, customers, regulatory agencies, and suppliers.

This position requires the following skills and attributes:

• Work effectively both 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, asking questions, challenging assumptions, and seeking clarification when appropriate.
• Communicate technical information clearly through strong verbal, written, presentation, and interpersonal skills.
• Maintain a customer-focused mindset with a 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.

The following skills and attributes are preferred:

• Hold a bachelors degree (BS) in biological sciences, physical sciences, life sciences, or another relevant technical discipline.
• Bring two to three years of relevant professional experience, preferably within the medical device, life sciences, pharmaceutical, healthcare, or regulated manufacturing environment.
• Contribute experience supporting biological testing, quality, regulatory, or laboratory operations functions.

• Competitive compensation range: $72500 - $75000/ year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates. 

Responsibilities

The Analyst supports and coordinates bioburden, sterility, and other biological testing programs tied to medical device manufacturing. Working as a quality analyst within the Biological Sciences function, the microbiology analyst maintains laboratory records, reviews and analyzes testing data, and supports compliance with applicable regulatory requirements, industry standards, and internal quality system expectations. Under the guidance of senior team members, the microbiology analyst works in a predominantly quality-focused role, with involvement in laboratory testing activities to support operational needs.

The role maintains awareness of evolving regulations and standards while providing analytical, technical, and operational support to internal stakeholders, customers, regulatory agencies, and suppliers.

Key Responsibilities

• Coordinate biological testing activities, including bioburden, sterility, and other testing programs conducted by external laboratories, along with related purchase requisitions and purchase orders, in support of routine quality and Research and Development (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 investigations related to testing outcomes, deviations, and performance metrics.
• Partner with Engineering, Manufacturing, Quality, and other cross-functional teams to coordinate the 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 that improve systems, workflows, and operational processes related to Biological Sciences activities.
• Maintain testing schedules, track project milestones, and communicate status updates to stakeholders.

Success in This Role Looks Like

• Deliver accurate, audit-ready laboratory records and testing documentation that hold up under regulatory and quality system review.
• Ensure biological testing programs run on schedule through strong coordination with external laboratories and cross-functional teams.
• Identify testing trends, deviations, and investigation needs early, supporting timely quality decisions.
• Drive continuous improvement in laboratory workflows and operational processes.
• Maintain compliance with evolving regulations, international standards, and internal quality requirements.
• Communicate technical findings clearly to internal stakeholders, customers, regulatory agencies, and suppliers.

Qualifications

This position requires the following skills and attributes:

• Work effectively both 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, asking questions, challenging assumptions, and seeking clarification when appropriate.
• Communicate technical information clearly through strong verbal, written, presentation, and interpersonal skills.
• Maintain a customer-focused mindset with a 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.