Quality Associate/Analyst

Quality Associate/Analyst Applied Medical - 3.1 Rancho Santa Margarita, CA Job Details Full-time $21 - $28 an hour 8 hours ago Benefits Paid holidays Tuition reimbursement 401(k) matching Qualifications Vendor relationship building Statistics Inspection tools Customer service Quality control statistical data analysis Technical Proficiency Full Job Description _________________________________________________________________________________: 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.

Position Description:

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. Key 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. Success in This Role Looks Like Consistently maintaining accurate quality documentation and ensuring timely resolution of non-conformances while meeting all regulatory compliance requirements. Building strong collaborative relationships with internal teams, external customers, and suppliers to facilitate effective quality communication and issue resolution. Demonstrating analytical excellence by identifying quality trends, implementing data-driven improvements, and contributing to measurable enhancements in product quality. Successfully supporting audit activities and quality management system maintenance while ensuring zero compliance findings and continuous system improvement. Proactively identifying process improvement opportunities and leading initiatives that result in enhanced quality processes and increased operational efficiency.

Position Requirements:

This position requires the following skills and attributes: 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

Preferred:

The following skills and attributes are preferred: 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

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 . Equal Opportunity Employer Applied Medical is an Equal 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 status protected by federal, state or local laws in the locations where Applied Medical operates.