Quality Control Inspector Ii

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.

Beta Bionics is a public benefit corporation. This means we are a for-profit company with obligations to serve both our public benefit mission and shareholders' interests. Beta Bionics is also a certified B Corporation; and as such accountable to operate with high standards of transparency, sustainability and accountability to our customers, employees, business partners, society, and the environment.

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!

*User must be carb aware.

Summary/Objective:

Responsible for incoming, in-process and final inspections of components, subassemblies and finished good products.

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]

• Inspect medical device components, subassemblies, and finished goods including plastic components and electronics
• Ability to use measurement equipment such as micrometer, calipers, and rulers
• Performs final release activities
• Ensures all Lot History Records (LHRs) and related quality records are complete and accurate
• Initiates nonconformance reports for product that does not meet requirements
• Performs simple mathematical calculations required to assist with inspections including product testing
• Works alongside Manufacturing Operators on a daily basis in support of the production schedule
• Supports the customer return process including product return intake, cleaning or decontamination and inspection

General Duties

• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and
• FDA regulations including compliance to EN ISO 13485 and Medical Device Quality Standards
• Assists in root cause analysis to resolve issues
• Provides feedback to Quality leadership regarding product nonconformances
• Works in accordance with quality system procedures
• Other duties as assigned by Supervisor
• Operates with high standards that are aligned to Certified B-Corp values
• Consider the beneficiaries of Beta Bionics' Public Benefit Mission with all actions and decisions

Required Education and Experience

• High school diploma, or equivalent
• 2-5 years of Quality Control Inspection experience in the medical device industry
• Understanding of sampling plan methods
• Ability to read and understand engineering drawings and specifications
• Proficiency required with word processing, spreadsheet and document management software
• Proficiency required with basic lab tools such as microscopes, calipers, and other inspection tools

Preferred Experience and Qualifications

• Experience in FDA/GMP/ISO environment preferred
• Experience working in an ISO Class 8 Controlled Environment
• 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

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
• While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear
• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus
• Employee must occasionally lift and/or move up to 40 pounds
• Wears personal protective equipment as required
• This position requires travel up to 5% depending upon business needs

Salary Range

$20 - $24 per hour

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.