Senior Quality Engineer

SeLux Diagnostics

SeLux Diagnostics

Quality Assurance
Boston, MA, USA
Posted on Thursday, August 31, 2023

The Senior Quality Engineer will join the Selux Quality Team in support of the Commercial Launch of our flagship product. This role will be the Lead Quality representative for day-to-day activities related to field support including System Installation, Distribution of Materials, Customer Feedback and Complaint handling, as well as helping to build out the procedures related to these functional areas. This is a great opportunity for a candidate with some commercial experience who wants to help direct the growth of an organization in its commercial efforts.

Key Responsibilities:

  • Primary Quality Liaison for all Commercial activities including Field Support, Medical Affairs studies, and incorporating Customer Feedback – either through complaint handling or assessment of potential new features.
  • Provide knowledge and guidance to internal team working with third party consumable manufacturers.
  • Lead process improvement efforts related to quality management systems procedures ahead of initial commercial launch of first product.
  • Serve as Quality Representative in design activities in support of Commercial Activity including design control deliverables (e.g., Verification and Validation, Risk Management) for new features, updated breakpoints, or new antibiotics.
  • Involvement with CAPA, NCR, and SCAR execution
  • Participate in Quality Management System activities such as internal audits, management review preparation, support of third-party audits.
  • Mentor colleagues with less experience in the Medical Device field with regards to medical device development within FDA compliance, leadership skills, and collaboration with engineering, science, and software groups
  • Other duties as needed.

Preferred Qualifications:

  • Bachelor’s degree in Biomedical Engineering, Biology, or closely related field
  • 5 years of industry experience in Medical Device Development and Commercialization
  • Working experience in later phases of device development, especially commercialization and post-market monitoring,
  • Strong communication skills to work with Field Support, Medical Affairs, Sales, and Customers
  • Role is required on site in Charlestown MA at least 3 days per week.

About Selux:

Antibiotics are lifesaving drugs, but rapidly emerging antimicrobial resistance is threatening that reality. Selux’s mission is to preserve the lifesaving efficacy of antibiotics by providing diagnostic results in hours, rather than days, and we are building a multidisciplinary team of talented individuals to help achieve this mission.

Joining the Selux team will give you an opportunity to harness your talent and advance your career by working in diverse groups of high-performing teammates tackling the most important healthcare challenges.

The customers and patients we serve have diverse life experiences and so do we. Selux is focused on hiring talented people from a wide range of backgrounds and providing an environment where everyone feels that they belong. We offer a competitive benefits package including healthcare, 401K match, stock option grants, open paid time off and supportive family leave policies.

Vaccination is a requirement of employment.

Selux Diagnostics is proud to be an inclusive workplace and an Equal Opportunity Employer.

Our Values

We believe every member of the Selux team is an essential contributor to our vision of preserving the lifesaving power of antibiotics and that our strength lies not only in what we do, but how we do it. These values represent the way that Seluxors approach their work. If you're someone who is relentless, collaborative, and adaptable, Selux might be just the place for you!

  • Relentless in the pursuit of our mission: We know that every second counts for patients and we are dedicated to saving lives and fighting antimicrobial resistance.
  • Collaboration drives innovation: We’re people people through and through. We love to work and play together and believe we are capable of more when we join forces as a community.
  • Adapt with grace: The only way to achieve our goals is by staying flexible and positive when faced with uncertainty. We see challenges as opportunities to grow.