Avive Solutions Inc.
1 day ago Be among the first 25 applicants
About Avive Avive Solutions, Inc. ( https://avive.life ) is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that. We build elegant, creative solutions to solve complex problems, aiming to provide rapid access to life‑saving defibrillation for all cardiac arrest victims.
Check out this short video that shows a glimpse of how our team is working to re‑think cardiac arrest response and save lives! https://www.youtube.com/watch?v=2p4zfOWo62E
Learn more about working at Avive: https://avive.life/careers/
About the Role The Senior Quality Engineer will support the development and manufacturing of Avive's electromechanical medical devices. This role plays a critical part in ensuring product quality and regulatory compliance across the product lifecycle, spanning manufacturing support, supplier quality management, and design control.
Responsibilities
Manufacturing Support
Provide quality engineering support for manufacturing operations (in‑house and contract).
Partner with Manufacturing to establish and maintain robust in‑process and final inspection criteria.
Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
Aid in production ramp‑up and collaborate cross‑functionally to address issues and drive continuous improvement projects.
Supplier Quality
Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
Collaborate with Product Development and Manufacturing to qualify new suppliers and components.
Manage supplier non‑conformances and corrective actions to ensure timely and effective resolution.
Design Control & Product Development
Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO 14971).
Author, review, and approve design control documentation (Design History File, risk management files, verification/validation protocols and reports).
Support design transfer activities to manufacturing.
Collaborate with cross‑functional teams to ensure design and manufacturing changes are assessed and implemented according to applicable regulations.
General Quality Systems & Leadership
Champion quality initiatives and improvements.
Perform gap assessment of external standards.
Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
Support internal and external audits.
Support regulatory submissions as needed.
Required Skills & Experience
5+ years of quality or manufacturing engineering experience in medical devices.
BS in Engineering (preferably Electrical, Mechanical or Biomedical).
Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601).
Strong interpersonal and communication skills.
Bonus Points For
Technical knowledge of electromechanical systems and software medical devices.
ASQ CQE, or related certification a plus.
Equal Employment Opportunity It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.
NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job‑related instructions and to perform any other duties/functions requested by their supervisor.
Anticipated salary range:
$140,000 - $160,000
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
#J-18808-Ljbffr
About Avive Avive Solutions, Inc. ( https://avive.life ) is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that. We build elegant, creative solutions to solve complex problems, aiming to provide rapid access to life‑saving defibrillation for all cardiac arrest victims.
Check out this short video that shows a glimpse of how our team is working to re‑think cardiac arrest response and save lives! https://www.youtube.com/watch?v=2p4zfOWo62E
Learn more about working at Avive: https://avive.life/careers/
About the Role The Senior Quality Engineer will support the development and manufacturing of Avive's electromechanical medical devices. This role plays a critical part in ensuring product quality and regulatory compliance across the product lifecycle, spanning manufacturing support, supplier quality management, and design control.
Responsibilities
Manufacturing Support
Provide quality engineering support for manufacturing operations (in‑house and contract).
Partner with Manufacturing to establish and maintain robust in‑process and final inspection criteria.
Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
Aid in production ramp‑up and collaborate cross‑functionally to address issues and drive continuous improvement projects.
Supplier Quality
Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
Collaborate with Product Development and Manufacturing to qualify new suppliers and components.
Manage supplier non‑conformances and corrective actions to ensure timely and effective resolution.
Design Control & Product Development
Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO 14971).
Author, review, and approve design control documentation (Design History File, risk management files, verification/validation protocols and reports).
Support design transfer activities to manufacturing.
Collaborate with cross‑functional teams to ensure design and manufacturing changes are assessed and implemented according to applicable regulations.
General Quality Systems & Leadership
Champion quality initiatives and improvements.
Perform gap assessment of external standards.
Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
Support internal and external audits.
Support regulatory submissions as needed.
Required Skills & Experience
5+ years of quality or manufacturing engineering experience in medical devices.
BS in Engineering (preferably Electrical, Mechanical or Biomedical).
Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601).
Strong interpersonal and communication skills.
Bonus Points For
Technical knowledge of electromechanical systems and software medical devices.
ASQ CQE, or related certification a plus.
Equal Employment Opportunity It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.
NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job‑related instructions and to perform any other duties/functions requested by their supervisor.
Anticipated salary range:
$140,000 - $160,000
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
#J-18808-Ljbffr