Senior Quality Engineer

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 quite literally 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 are a dynamic organization that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.

Avive is taking a fresh approach to addressing this decades-old problem by innovating AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to SCA emergencies. We believe that this unique combination of deploying advanced – yet still accessible – hardware, and software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.

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 will play a critical role in ensuring product quality and regulatory compliance across the product lifecycle, with responsibilities spanning manufacturing support, supplier quality management, and design control.

What You'll Do:

- Provide quality engineering support for manufacturing operations (in-house and contract manufacturing).
- 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.
- Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
- Collaborate with Product Development and Manufacturing functions to qualify new suppliers and components.
- Manage supplier non-conformances and corrective actions to ensure timely and effective resolution.
- Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO14971).
- 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.
- Champion for quality initiatives and improvements.
- Performs gap assessment of external standards.
- Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
- Support internal and external audits.
- Supports 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 job-related duties/functions requested by their supervisor.

Anticipated salary range: $140,000 - $160,000

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