Are you interested in working with the World’s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest!

 

We are looking for a Software Quality Manager to join our growing team in Indianola, PA (onsite).

 

Top 3 Must Haves:
1. Ensuring adherence to applicable standards and regulations such as IEC 62304, FDA 21 CFR 820.30, and EU MDR.
2. Responsible for lifecycle software quality oversight of Class 1 and Class 2 medical devices; primarily Software as a Medical Device (SaMD) and Software as a Service (SaaS).
3. Working knowledge of applicable industry standards (e.g.: ISO 13485, IEC 62304, ISO 14971)

 

Duties and Responsibilities

Responsible for lifecycle software quality oversight of Class 1 and Class 2 medical devices; primarily Software as a Medical Device (SaMD) and Software as a Service (SaaS). Ensuring adherence to applicable standards and regulations such as IEC 62304, FDA 21 CFR 820.30, and EU MDR. As a Project Core Team Member, provides E2E cross functional software lifecycle process guidance, expertise, and oversight. Reviews, supports, and ensures the integration of quality in all software lifecycle deliverables including requirements, software risk analysis, design, development, documentation, integration, test, verification, validation, and release to ensure process and Quality System compliance Oversees software milestone reviews as defined by the product development process. Leads Quality Element Teams for software development initiatives. Works hand-in-hand with Regulatory in both strategy development and execution across entire software lifecycle. Supports internal and external audits as required. Identifies and actively takes lead in process and Quality System improvements. Lead the implementation and maintenance of applicable software certifications (e.g.: Hitrust, EuroPriSe, ISO 27001) Support GxP validation activities Supports Software Supplier audits Supports Nonconformance and CAPA processes to assure timely and compliant assessments and processes of deviation and corrective/preventative actions.

 

Required Qualifications:

Bachelor’s Degree in Computer Science or Engineering 7+ years engineering, software engineering or software quality Functional knowledge and expertise in medical device software lifecycle processes, regulatory requirements, international standards, and software risk management. Working knowledge of applicable industry standards (e.g.: ISO 13485, IEC 62304, ISO 14971) Ability to manage multiple tasks/projects based on priorities Strong oral and written communication skills Strong collaborative/teamwork behaviors

 

Preferred Qualifications

Knowledge of UI applications, Cloud based applications, database operations

Other qualifications of interest include:  
GDPR
Artificial Intelligence
Cybersecurity
Cloud Computing
Data Quality and Interoperability
Data Security/Compliance (Hitrust, EuroPriSe, ISO 27001)

Benefits
Why QualiTest?

Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities. Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career. Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us. Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers. Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan. Take care of health with enrolment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate. Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more. Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym! Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth. We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements. Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless! A Competitive pay, the salary range for the role is $110,000 - $120,000. Intrigued to find more about us? Visit our website at https://www.qualitestgroup.com/ If you like what you have read, send us your resume and let’s start talking!