Quality Systems Engineer I/II – Test Method Validation - Applied Medical

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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

Join our innovative team as a Quality Engineer, where you will play a pivotal role in ensuring the highest standards of medical device safety and efficacy. Specializing in Test Method Validation, you will spearhead critical assessments to guarantee that our testing processes are precise, reliable, and compliant with regulatory standards. Your expertise will directly contribute to advancing healthcare solutions, impacting patient lives worldwide.

Key Responsibilities:

• Develop Test Methods: Ensure product performance and effectiveness by creating, reviewing, approving, and implementing test methods that align with user needs, design requirements, and test method acceptance criteria.
• Design and Create Test Equipment: Develop, build, and deploy test equipment tailored to meet the specific requirements of both internal and external stakeholders.
• Validate Test Methods: Develop detailed protocols for conducting test method validation. Perform statistical analysis, including Analysis of Variance (ANOVA) and Gage Repeatability and Reproducibility (Gage R&R), to evaluate the results and document the findings in a comprehensive report.
• Investigate and Document Anomalies: Identify, document, and resolve anomalies discovered during testing.
• Provide Technical Leadership and Mentoring: Lead and mentor team members, fostering collaboration and maintaining excellent relationships with internal and external stakeholders, while interpreting relevant regulations, standards, and guidance documents.
• Ensure Compliance and Quality Improvement: Execute all activities in adherence to the quality system, safety regulations, and company policies, committing to continuous quality improvements and striving to meet or exceed customer expectations.

Performance Objectives:

Within your first 30 days:

• Complete all Applied Learning foundational courses with a passing grade of 95% or above, demonstrating rapid integration into company processes.
• Gain a thorough understanding of the company’s quality systems, policies, and procedures related to test method validation.
• Review existing test methods, validation protocols, and reports to understand current practices and areas for improvement.
• Establish working relationships with Product and Process Development teams, quality assurance personnel, and other relevant stakeholders.

Within your first 60 days:

• Draft initial plans for developing and validating test methods for assigned projects, ensuring alignment with regulatory standards and internal requirements.
• Actively collaborate with R&D and Process Development teams to understand user needs, design requirements, and acceptance criteria for test methods.
• Start designing and specifying requirements for necessary test equipment, ensuring it meets the needs of the test methods being validated.
• Execute preliminary tests on current methods and document any anomalies or issues encountered, proposing initial solutions.
• Actively contribute to team meetings, providing insights and updates on test method validation activities and progress.

Within your first 90 days to one year:

• Successfully complete validation of at least one test method, generating comprehensive protocols and reports. Utilize statistical analysis tools such as ANOVA and Gage R&R to analyze results.
• Investigate, document, and resolve any anomalies discovered during preliminary testing.
• Finalize the design and creation of required test equipment, ensuring it is ready for use in further validations.
• Identify and propose at least one quality improvement initiative related to test method validation processes, aligning with the company's commitment to continuous improvement and customer satisfaction.

Position Requirements

• Bachelor's Degree or higher in Engineering or a scientific field.
• Experience in test method development and validation.
• Basic understanding of statistical techniques.
• Experience in performing Gage R&R, ANOVA, and measurement system analysis using MINITAB, or equivalent software.

Preferred

• Minimum of one years' experience in medical device, healthcare, or other regulated industries.
• Experience in Medical Device Quality Systems standards and regulations, including International Organization for Standardization (ISO) 13485 Quality Management System (QMS), 14971 Risk Management, Medical Device Regulation (MDR), Title 21 Code of Federal Regulations Part 820 (21CFR820), and other relevant standards.
• Experience in using Minitab, SolidWorks, or similar software.
• Experience in using Systems, Applications, and Products (SAP) Product Lifecycle Management (PLM) or a similar Enterprise Resource Planning (ERP) system.

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles.

Benefits

• Competitive compensation range: $70000 - $90000 / 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 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.