Quality Systems Engineer (Hardware & Production), Remote Portugal
Software Engineering, Other Engineering, Quality Assurance
Posted on Thursday, September 28, 2023
Sword Health is on a mission to free two billion people from pain as the world’s first and only end-to-end platform to predict, prevent and treat pain.
Delivering a 62% reduction in pain and a 60% reduction in surgery intent, at Sword, we are using technology to save millions for our 2,500+ enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, General Catalyst, and Khosla Ventures.
Recognized as a Forbes Best Startup Employer in 2023, this award highlights our focus on being a destination for the best and brightest talent. Not only have we experienced unprecedented growth since our market debut in 2020, but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $2 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our impact.
Joining Sword Health means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.
This is an opportunity for you to make a significant difference on a massive scale as you work alongside 800+ (and growing!) talented colleagues, spanning two continents. Your charge? To help us build a pain-free world, powered by technology, enhanced by people — accessible to all.
SWORD Health is a health care company that provides virtual and digital physical therapy. Sword is committed to providing high-quality medical devices (SW and HW) that improve patient outcome and safety.
As part of our ongoing commitment to excellence, we are seeking a talented and detail-oriented Quality Systems Engineer (Hardware & Production).
Reporting to the Sr. QARA Director, as Quality Engineer (Hardware & Production), you will play a crucial role in ensuring the quality and regulatory compliance of the hardware components of medical devices and in ensuring quality throughout the production lines.
You will collaborate with cross-functional teams, including research & systems, hardware development, supply chain, and production regulatory affairs, to uphold the highest standards of safety and effectiveness.
- Hardware Quality Assurance:Develop and implement quality assurance processes and procedures specific to hardware development for medical devices.
- Guide product development teams through our QMS and Design and Development process to ensure hardware is developed in compliance with internal procedures as well as FDA and ISO and other regulatory bodies requirements;
- Oversee Design Transfer activities into product from a quality perspectiveCollaborate with cross-functional teams to establish and maintain quality standards for medical device hardware production;
- Develop and implement quality control procedures, inspection controls, and testing methodologies.
- Conduct regular audits of production processes to identify and rectify non-compliance issues;
- Process Improvement:Identify opportunities for process optimization and efficiency enhancement within the production environment.
- Overseeing the QC techniciansPropose and implement corrective and preventive actions (CAPAs) to address quality issues and drive continuous improvement;
- Regulatory compliance:Stay updated and provide guidance on relevant industry standards, regulations, and guidelines (e.g., ISO13485, FDA QSR, FDA 21 CFR 820.30, IEC 14971) to ensure compliance in all aspects of hardware production;
- Supplier Management:Evaluate and qualify suppliers, ensuring they meet quality and performance requirements. Conduct supplier audits and establish quality agreements to maintain high standards of incoming components and materials;
- Root Cause Analysis:Lead investigations into quality incidents, utilizing tools such as 5 Whys, Fishbone Diagrams, and Failure Modes and Effects Analysis (FMEA);
- Implement corrective actions to prevent recurrence of identified issues.
- Conduct root cause analysis for Non Conforming Products and implement corrective and preventive actions (CAPAs) as necessary;
- Risk management:Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with hardware development for medical devices;
- Support the creation of hardware risk analyses and test strategies to ensure safe and reliable products are launched to SWORD’s high quality standards;
- Documentation and Reporting:Prepare and Maintain accurate and comprehensive documentation of quality-related activities, including inspection reports, test results, and compliance documentation. to software quality activities, including reports, test plans, and risk assessments;
- Prepare and deliver regular reports on quality metrics and key performance indicators (KPIs) to management.
- Collaboration and Communication:Work closely with software development and production teams to provide guidance on quality-related matters and facilitate effective communication between teams;
- Training and Support:Provide training and support to internal teams on quality-related processes and procedures related to hardware development and production.
Skills and expertise:
- Bachelor's degree in Science, Engineering or related discipline;
- 3+ years of experience in Quality Engineering (Hardware and/or Production) or a related role within the medical device or pharmaceutical industry;
- Experience in medical device new product development preferred;
- Work experience in medical devices, including QMS, CAPA, Document control is required;
- Familiarity with relevant quality standards and regulations: Quality Management System ISO 13485, FDA 21 CFR 820.30, IEC 14971 Risk Management;
- Experience with risk management methodologies (e.g. FMEA) and with statistical analytical tools;
- Strong analytical skills and proficiency in root cause analysis techniquesSix Sigma or Lean Manufacturing certification is preferred;
- Excellent analytical, problem-solving and communication skills;
- Fluent in English
The Sword program allows members to complete a personalized physical therapy program from the comfort of home, with continued support and supervision from one of our talented Sword specialists.
Sword’s personalized care is more effective than traditional standards of care, and has proven to deliver best-in-class clinical results. Since breaking into the market less than three years ago, Sword has worked with insurers, health systems, and employers in the U.S., Canada, Europe, and Australia to make high quality musculoskeletal care accessible to everyone.
This is an opportunity to join Sword during a time of hyper growth and expansion. After our recent $2bn valuation, we’re excited to continue accelerating our impact by scaling with high caliber people with passion, commitment and energy to create and deliver technologies, services and products that drive human progress forward.
We welcome you to join our mission, to make a difference on a grand scale and play a pivotal role with a global team at Sword– working alongside great people pioneering novel products and cutting edge technologies.
US Sword Benefits:
*Eligibility for Essential benefits: Full-time employees regularly working 25+ hours per week
Comprehensive health, dental and vision insurance
Discretionary PTO Plan
US Sword Perks:
Flexible working hours
Internet Stipend for remote working
Paid Company Holidays
Free Digital Therapist for you and your family
Portugal - Sword Benefits:
Health, dental and vision Insurance
Portugal - Sword Perks:
Remote Work Allowance
Flexible working hours
Work from home
Snacks and Beverages
Unlimited access to Coursera Learning Platform
*US Applicants Only: Applicants must have a legal right to work in the United States, and immigration or work visa sponsorship will not be provided.*
SWORD Health, which includes SWORD Health, Inc. and Sword Health Professionals (consisting of Sword Health Care Providers, P.A., SWORD Health Care Providers of NJ, P.C., SWORD Health Care Physical Therapy Providers of CA, P.C.*) complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.