Sr. QA Engineer

The Company:

Proteus Digital Health® is a privately held company, funded by leading institutional and corporate investors, including Novartis, Otsuka, Oracle and Kaiser Permanente Ventures. Armed with an intellectual property portfolio that includes more than 440 issued patents and led by some of the brightest minds in technology, pharmaceuticals, and healthcare, Proteus is enabling a new category of therapy: Digital Medicine. These offerings include widely used drugs, formulated so they communicate when they have been taken; a wearable patch that detects medicines and captures physiologic response; mobile applications to support patient self-care and physician decision-making; and data analytics to serve the needs of health system managers. The FDA granted its first approval of a Digital Medicine, Abilify Mycite® on November 13, 2017. Abilify Mycite® is a drug-device combination product of Otsuka’s aripiprazole, an atypical antipsychotic, embedded with Proteus’ ingestible sensor that communicates with Proteus’ wearable sensor patch and a smartphone application.

The Product: Proteus Discover

Proteus Discover is a Digital Medicine offering that measures medication treatment effectiveness and helps physicians, care teams, and patients improve clinical outcomes. Proteus Discover provides the tools needed for health organizations to build patient engagement, efficiency and measurement into the delivery of care, and an opportunity to mitigate the high costs of uncontrolled diseases.

Join Us:

Come to join our unique collection of innovative scientists, engineers, market makers, designers, doctors, developers, clinicians, and other digital health industry pioneers, and assist us with achieving our compelling vision, “Healthcare for Everyone, Everywhere.”

Learn more about what we do (video): https://youtu.be/D65XJqKNVvI

Summary

In this role, you will be responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Familiar with a variety of the field’s concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. Should have a successful record in problem-solving techniques, manufacturing, a good influencer to the team, show consistency and experience in Quality Assurance Regulations and documentation techniques; have good working knowledge of CAPA systems, 21 CFR Part 820, 21 CFR Part 11, ISO 13485 and ISO 14971. Responsible for managing the company’s professional services adhering to safety and compliance with regulatory requirement. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is required. All of this while working cross-functionally with several internal teams. But it doesn’t end there. Here’s a summary of this great opportunity:

• Bachelor’s degree in Engineering or related field

• Minimum 5 years of related experience in Quality in pharmaceutical/medical device industry
• Previous experience with Quality Systems around scale-up and high-volume device/drug manufacturing
• Thorough knowledge of ISO and FDA regulations
• ASQ certifications for CQE, CQA, or equivalent highly recommended
• Technical writing proficiency (e.g., protocols, analytical reports, DCOs, SOPs, Test Methods, procedures)
• Practical knowledge of SPC, process capability, Gage R&R, DOE, and FMEA and other quality engineering tools such as statistical data analysis, and inspection techniques
• Solid problem analysis and decision-making ability and leadership skills
• Computer literacy with preference to Microsoft Professional Office Suite, i.e., Excel, Word, Access, PowerPoint, and Microsoft Project
• Excellent verbal and written communication skills
• Strong organizational skills along with strong attention to detail
• Ability to work both independently and collaboratively with small, cross-functional teams

Ready for the ride of your life? We’re looking forward to receiving your resume!

We provide our employees with a great benefits package, which includes: medical/dental/vision insurance, 401K, paid time off (PTO)including your birthday off, employee stock options, a bright & awesomely designed physical workspace, a complimentary wearable device (i.e. Fitbit), fitness centers, and, of course free snacks & beverages.