Quality Associate/Analyst

Applied Medical•Rancho Santa Margarita, CA

1d•$21 - $28

About The Position

Applied Medical is seeking a Quality Associate or Quality Analyst to support our quality assurance operations and regulatory compliance initiatives. This opportunity combines quality management system expertise with continuous improvement initiatives to maintain high standards in medical device manufacturing. Depending on experience level, the successful candidate will manage non-conformance processes, coordinate documentation updates, and collaborate with cross-functional teams to drive product quality and regulatory compliance. The role may include mentoring responsibilities and liaison duties with internal teams and external customers.

Requirements

For Associate level: High school diploma or equivalent with two years of related quality experience, or Bachelor's degree in engineering, quality management, or technical discipline
For Analyst level: Bachelor's degree in business, engineering, or technical discipline, or minimum of two years of work experience in quality or related areas
Strong analytical and detail-oriented approach with ability to work independently while collaborating effectively within team environments
Excellent written and verbal communication skills with capability to present quality data and findings to various stakeholders and management levels
Assertive communication style with confidence to ask questions, seek guidance, and provide feedback to ensure quality standards are maintained
Customer service orientation with friendly attitude and commitment to meeting or exceeding internal and external customer expectations
Multi-tasking abilities with strong project prioritization skills to manage multiple quality initiatives simultaneously
Proficiency with quality tools, inspection equipment, and statistical analysis techniques for product and process evaluation

Nice To Haves

Knowledge of database management systems, statistical analysis software, and quality trending methodologies for data-driven decision making
Hands-on manufacturing experience in medical device production, quality control, or related technical operations with understanding of industry standards
Experience with protocol execution, technical report writing, and regulatory documentation preparation for quality management systems
Familiarity with ISO 9001 quality management standards, ISO/IEC 17025 laboratory quality systems, or medical device regulations
Background in quality investigations, root cause analysis methodologies, and Good Manufacturing Practices (GMP) compliance

Responsibilities

Monitor and evaluate non-conformances by conducting thorough investigations, documenting findings, and maintaining comprehensive quality documentation to ensure regulatory compliance.
Coordinate document control and quality management system maintenance including procedure changes, module updates, and database management to ensure accurate documentation.
Compile and analyze quality metrics using statistical techniques to track performance trends, identify improvement opportunities, and support data-driven decision making.
Facilitate customer feedback resolution by coordinating with internal teams, investigating quality issues, and issuing formal closing letters to maintain customer satisfaction.
Participate in internal and external audits by preparing documentation, supporting audit activities, and implementing corrective actions to maintain regulatory compliance.
Collaborate with production teams, engineering departments, and suppliers to ensure manufacturing requirements and quality specifications are consistently met.
Propose and contribute to process improvement projects by identifying inefficiencies, developing solutions, and working with cross-functional teams to enhance quality processes.
For Analyst level: Coordinate training initiatives, develop quality procedures, and provide leadership support to Quality Associates through mentoring and guidance.

Benefits

Competitve compensation range: $21-$28 / hour (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 employee 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.