About Beta Bionics

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions – and a better life for those living with diabetes – with the world's first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates. The only number needed to get started with the iLet Bionic Pancreas is a user's weight – the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management.
*User must be carb aware

Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact.

Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team!

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Summary/Objective:

The Quality System Specialist is responsible for Quality Systems related activities including document control, CAPA, internal auditing, and general compliance-related activities.

Essential Duties and Responsibilities

[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]

Document Control and Training Duties

• **__**Acts as secondary support to Document change Order (DCO) process, when necessary
• Identifies training requirements related to new/revised procedures and employee hires and coordinates training completion alongside Document Control. Maintains procedure training matrices to ensure that personnel training requirements are defined, training accomplishments are documented, and appropriate corrective actions are taken
• Performs comprehensive document reviews to verify completeness of Device Master Records and generates status reports

Quality Systems Duties

• Manages the CAPA process

• Supports the Quality Systems Department in development of applicable eQMS modules for implementation

• Facilitates the timely completion of assigned corrective and preventive actions

• Establishes and maintains Standard Operating Procedures, Work Instructions and Forms related to areas of responsibility

• Facilitates the implementation of an electronic Quality Management System

• Establishes and maintains Quality Plans to document quality-related projects and continuous improvement plans

• Reports upon key Quality Metrics

General Duties

• Participates in third party and internal quality audits involving areas of responsibility

• Advises and trains other Company personnel concerning areas of responsibility

• Communicates information related to quality management system effectiveness

• Works in accordance with quality system procedures

• Other duties as assigned by Manager

Work Location

• Five days a week, Monday through Friday, in the Irvine Office

Required Education and Experience

• Associate Degree or Higher or equivalent certification is required
• Minimum five (5) years' experience in Quality Systems, Quality Control or Document Control in a manufacturing environment required, medical device industry preferred
• Experience in internal and/or external auditing to Quality System requirements
• Experience required in design, implementation, and maintenance of quality management systems for medical product development, manufacturing, distribution, and post market surveillance
• Experience with metric reporting

Preferred Experience and Qualifications

• Good verbal and written communication skills including ability to prepare written procedures and reports
• Good organizational and planning skills
• Good math skills
• Working knowledge of electronic file management tasks using MS Windows software
• Working knowledge of word processing (MS Word), spreadsheet (MS Excel), and document management (Adobe Acrobat) software
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential
• Good organizational and communication skills, including ability to represent the company to both internal and external audiences
• Proficient or able to learn how to manage internet cloud storage services such as Google Drive and/or electronic document control systems
• Knowledge of domestic and international regulations and standards related to medical device manufacturing
• Proficiency desired with application of statistical techniques for manufacturing and quality systems

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopier, and scanners.

Physical Demands

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with co-workers
• This position requires travel up to 5% depending upon business needs

Salary Range

$65,000 - $85,000

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement

It is the policy of Beta Bionics 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, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.