Quality Engineer

The Quality Engineer will primarily support the Supplier Quality and Complaint Handling organizations, focused on mitigating quality risks impacting Bigfoot Biomedical and its customers. This individual will be responsible for identifying, escalating, and supporting resolution of supplier deviations that result in disruptions to manufacturing, quality defects, or complaints from the field. This individual will quickly respond to changes in regulations and changes to Bigfoot Biomedical's manufacturing processes to ensure that quality events in the supply chain are resolved in a timely and compliant manner. This individual will also be responsible for supporting Complaint Handling and Returned Material Authorization processes at Bigfoot Biomedical, performing activities and generating quality records that are compliant with all applicable international regulatory requirements (e.g. FDA regulations, ISO 13485, European MDR/IVDR etc.).

Essential Duties and Responsibilities:

• Support Bigfoot Biomedical's supplier quality management program and maintenance of the Approved Supplier List, including: supplier monitoring, performance scorecarding, and certificate management.
• Escalate Manufacturing, Quality, Technical and supply issues to initiate internal investigations to improve overall Quality.
• Utilize problem-solving skills to support root cause analysis and robust corrective action plans, as well as assist with implementation of quality improvements in collaboration with internal and external stakeholders.
• Initiate and maintain quality records for the return, receipt, safe handling, disinfection, and disposition of Bigfoot's commercial products.
• Support complaint intake and investigation activities in compliance with regulatory requirements.
• Proactively seek out opportunities for the continuous improvement of Bigfoot Biomedical's Quality Management System and support of other Quality initiatives.
• Ability to support manufacturing, Returned Material processing, and complaints investigation activities onsite at Bigfoot Biomedical's headquarters in Milpitas, CA.

Experience Requirements:

• 1 to 3 years in Quality Engineering (relevant intern experience acceptable); preferably, in the medical device industry
• Basic knowledge of medical device regulations, standards, guidelines, directives, global and domestic standards as applicable.
• Proficient in Excel, including use of Pivot Tables, charts, lookups, and data validation.

Additionally, the ideal candidate will possess the following: :

• Excellent organizational skills and capacity to handle multiple areas of responsibility concurrently.
• Ability to build strong relationships and clearly communicate technical information with a quality focus to both internal and external partners.
• Experience working in compliance with 21 CFR 820, ISO 13485:2016, ISO 14971 and ISO 62304.
• Prior auditing experience to FDA QSR and ISO standards.
• Flexible and adaptable in a fast-paced, start-up environment.
• Team player/builder; possess a can-do attitude.
• Ability and desire to be proactive not just reactive; a questioning mindset.
• An analytical thinker; one who probes for answers and looks for innovative ways of doing things.

Education Requirements:

• Minimum of a bachelor's degree in Engineering, biological sciences, or similar technical field is required.
• Lead Auditor certification preferred; training can be provided.