Quality Engineer

Job Title: Quality Engineer

Company: Active Protective Technologies, Inc.

Location: Hybrid, with headquarters in Fort Washington, PA

About Active Protective Technologies:

Active Protective Technologies is a medical device startup committed to revolutionizing fall injury prevention and improving the lives of older adults. Our flagship product, the Tango Belt, integrates cutting-edge technology into a wearable device to mitigate fall-induced major hip injuries, a leading cause of disability and fatal injury in older adults. The Tango Belt was designated a Breakthrough Device by the FDA to recognize its potential to significantly improve the standard of care for this debilitating condition. For more info on our mission and product, please visit www.tangobelt.com.

Position Overview:

This position provides technical expertise in support of Quality System processes and Manufacturing. Quality Engineer works closely with the product-development team and with contracted manufacturers, under Quality Manager’s supervision. This position is ideal for an engineer at an early career stage who enjoys working with technical details and with product, and who wishes to gain new skills and take on new responsibilities. The ideal candidate is independently driven, responsible, flexible, resourceful, skillful, amicable and communicative. 

Roles & Responsibilities:

1. Product Quality Oversight: Work to understand product and lead Quality initiatives to make improvements; Assist in performing defect investigations. Technical knowledge or skill in the following areas is a plus: automative airbag systems, PCBA and electronics, plastics, network communications, embedded software, mobile applications, desktop applications, cloud computing.
2. Manufacturer Quality Oversight: Work with contract manufacturers in establishing manufacturing lines with complete documentation, including IQ-OQ-PQ validation, PPAP, pFMEA; Assist Engineering and/or Supply Management by performing Supplier Qualification and by resolving Quality issues through NCR, PRNCR, and SCAR. Technical knowledge or skill in the following areas is a plus: automated quality control systems, electronics manufacturing, automative airbag manufacturing, tools machining.
3. Development Process: Assist in representing Quality in Product Development, including Product Development and Risk Management, providing guidance to teams and fulfilling requirements. Help ensure that deliverables are completed and accurate.
4. Process Validation: Test, document and implement equipment and processes using IQ-OQ-PQ methodology (or other acceptable method)
5. Process Development & Improvement: Develop, implement and help to maintain Quality System Processes, including supporting documentation (e.g. SOP, WI, FORM, records). Work with functional stakeholders to improve systems and processes.
6. Computer System Validation: Test, document and implement computer systems using risk based validation methods.
7. Maintain Quality System: Assist in maintaining the Quality System by performing Quality Audits, NCR investigations, CAPA investigations, Quality inspections, Document Inspection, Complaint Investigations, etc.
8. Educate & Resolve Issues: Work with functional stakeholders to resolve Quality issues, while educating concerning Quality processes. 

Qualifications:

• Minimum Work Experience: A minimum of 2 years in a medical device, automotive or electronics company.
• Minimum Education: B.A. or B.S. in an Engineering discipline.
• Technical Knowledge: A working knowledge of medical device processes requirements and standards, including FDA QSR, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, GDP. Knowledge of manufacturing processes as plus. Ability to code or work in software a plus. Knowledge of cybersecurity standards a plus. Knowledge of HIPAA standards a plus. 
• Systems Knowledge: Experience with Greenlight Guru, Bitbucket, ERP systems, Engineering drawing systems, PLM, SBOM systems, Automated Software Testing, a plus. 
• Personal Skills: Strong communication skills, both written and verbal. Strong ability to work collaboratively with team-members, and to work under business direction. 

Physical Requirements:

· Possible business travel

• Must be fully vaccinated for COVID-19 (i.e., at least 2 weeks after last dose) and, if hired, present proof of vaccination by start date.

How to Apply:

If you are experienced in Quality, with a strong desire to revolutionize fall injury prevention and make a meaningful impact on the lives of older adults, we encourage you to apply. To submit your application, please send your resume and a cover letter to careers@activeprotective.com. Please include "Quality Engineer Application" in the subject line. You may also submit a short technical writing sample if you wish (e.g. SOP, WI, Test Protocol, Test Report), and copies of any relevant certificates. 

Active Protective Technologies is an equal opportunity employer. We value diversity and welcome applications from candidates of all backgrounds.