Autonomous Medical Devices Incorporated
Senior Quality Assurance Engineer
Autonomous Medical Devices Incorporated, Santa Ana, California, United States, 92725
Overview
Senior Quality Assurance Engineer role at Autonomous Medical Devices Incorporated (AMDI). This onsite position is located in Santa Ana, CA and requires candidates within a 25 mile radius. Responsibilities
Provides QA guidance and support throughout the entire design control and product realization processes to ensure that medical device products meet all applicable regulations and standards (e.g., ISO 13485, 21 CFR Part 820, other FDA regulations and guidance, and applicable ISO/IEC standards). Collaborates with R&D, Engineering and Operations to support new product development and improve product design. Leads risk management activities, including creating or reviewing risk management plans, risk assessment documents, and risk management reports. Writes or reviews validation protocols and reports. Works with supplier quality and supply chain groups to ensure supplier development and alignment with quality requirements. Verifies configuration management and risk analysis records are properly addressed, accurate, and maintained. Supports software development activities to ensure regulatory compliance. Leads design transfer activities pertaining to product quality and regulatory compliance. Ensures design changes are processed in accordance with current change control requirements. Participates in and supports other QMS processes, including NCR investigations, CAPA processes, internal audits, and process validations. Completes assigned tasks on schedule and identifies resolutions for issues that may affect product development timelines. Coordinates resolution of potential quality assurance deficiencies discovered during product realization. Other projects and duties as assigned. Qualifications
Bachelor's degree in engineering, science, or related field required; advanced degree preferred. Minimum of 7 years of quality engineering experience in the medical device industry, with at least 2 years in new product design and development. Hands-on experience with design control processes and mastery knowledge of ISO 13485:2016 and 21 CFR Part 820. Hands-on experience with risk management and mastery knowledge of ISO 14971. Strong organizational skills and attention to detail. Excellent documentation skills (writing clear, concise verification/validation/qualification protocols and reports, work instructions, and investigation reports). Strong interpersonal skills and ability to work as a team, establishing professional relationships with colleagues and suppliers. Ability to interpret trends and data and translate findings into actions and improvements. Strong verbal and written communication skills. Proficiency with QMS software; tech-savvy and quick to learn new software. Desired Skills and Traits
Collaborative and inclusive work environment contributor. Results-oriented with a drive for progress and excellence. High standards, ownership, and commitment to outcomes. Proactive, positive team player who helps others. Experience with software development and software V&V, and mastery of ISO/IEC and FDA requirements for software. IVD medical device experience. Quality engineering certification (ASQ CQE or CQA) desired. Work Environment
In-person position at a computer workstation for long periods; occasional work in production and laboratory environments. Salary Range
The estimated base salary range for this position is $100,000 - $135,000 annually. The base pay may be updated during the hiring process based on qualifications, experience, and level of education. Actual base salary offers are determined by factors including qualifications, experience, and education. Benefits
Company-provided lunch at on-site locations. 401(k) match Health insurance (medical, dental, vision) and Life Insurance paid by employer Paid vacation, sick days, and holidays Tuition reimbursement Casual dress code Employee discounts on activities and services Monthly company-wide socials and activities Equal Opportunity
Autonomous Medical Devices Incorporated is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law. AMDI will not accept unsolicited resumes from any source other than directly from a candidate. Agencies must obtain advance written approval from AMDI’s internal Human Resources team to submit resumes only in conjunction with approved contracts.
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Senior Quality Assurance Engineer role at Autonomous Medical Devices Incorporated (AMDI). This onsite position is located in Santa Ana, CA and requires candidates within a 25 mile radius. Responsibilities
Provides QA guidance and support throughout the entire design control and product realization processes to ensure that medical device products meet all applicable regulations and standards (e.g., ISO 13485, 21 CFR Part 820, other FDA regulations and guidance, and applicable ISO/IEC standards). Collaborates with R&D, Engineering and Operations to support new product development and improve product design. Leads risk management activities, including creating or reviewing risk management plans, risk assessment documents, and risk management reports. Writes or reviews validation protocols and reports. Works with supplier quality and supply chain groups to ensure supplier development and alignment with quality requirements. Verifies configuration management and risk analysis records are properly addressed, accurate, and maintained. Supports software development activities to ensure regulatory compliance. Leads design transfer activities pertaining to product quality and regulatory compliance. Ensures design changes are processed in accordance with current change control requirements. Participates in and supports other QMS processes, including NCR investigations, CAPA processes, internal audits, and process validations. Completes assigned tasks on schedule and identifies resolutions for issues that may affect product development timelines. Coordinates resolution of potential quality assurance deficiencies discovered during product realization. Other projects and duties as assigned. Qualifications
Bachelor's degree in engineering, science, or related field required; advanced degree preferred. Minimum of 7 years of quality engineering experience in the medical device industry, with at least 2 years in new product design and development. Hands-on experience with design control processes and mastery knowledge of ISO 13485:2016 and 21 CFR Part 820. Hands-on experience with risk management and mastery knowledge of ISO 14971. Strong organizational skills and attention to detail. Excellent documentation skills (writing clear, concise verification/validation/qualification protocols and reports, work instructions, and investigation reports). Strong interpersonal skills and ability to work as a team, establishing professional relationships with colleagues and suppliers. Ability to interpret trends and data and translate findings into actions and improvements. Strong verbal and written communication skills. Proficiency with QMS software; tech-savvy and quick to learn new software. Desired Skills and Traits
Collaborative and inclusive work environment contributor. Results-oriented with a drive for progress and excellence. High standards, ownership, and commitment to outcomes. Proactive, positive team player who helps others. Experience with software development and software V&V, and mastery of ISO/IEC and FDA requirements for software. IVD medical device experience. Quality engineering certification (ASQ CQE or CQA) desired. Work Environment
In-person position at a computer workstation for long periods; occasional work in production and laboratory environments. Salary Range
The estimated base salary range for this position is $100,000 - $135,000 annually. The base pay may be updated during the hiring process based on qualifications, experience, and level of education. Actual base salary offers are determined by factors including qualifications, experience, and education. Benefits
Company-provided lunch at on-site locations. 401(k) match Health insurance (medical, dental, vision) and Life Insurance paid by employer Paid vacation, sick days, and holidays Tuition reimbursement Casual dress code Employee discounts on activities and services Monthly company-wide socials and activities Equal Opportunity
Autonomous Medical Devices Incorporated is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law. AMDI will not accept unsolicited resumes from any source other than directly from a candidate. Agencies must obtain advance written approval from AMDI’s internal Human Resources team to submit resumes only in conjunction with approved contracts.
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