MidwestQMS
Registered
Hiring: RQA Engineer
About the role
UNandUP (Unmet Needs and Underserved Populations) LLC is a dynamic start-up company founded by established entrepreneurs to advance high-risk medical technologies from lab bench to clinic. We are seeking a passionate, motivated regulatory and quality engineer to join our growing team in St. Louis, Missouri.
RQA engineers design processes to foster effective, safe, and compliant development throughout the product life cycle; their work touches every stage of product evolution from preclinical prototyping to initial production. As core members of the team, RQA engineers work closely with engineers from varied disciplines to craft practical, efficient procedures and workflows that achieve 21 CFR 820 and ISO 13485 compliance.
The ideal candidate brings a collaborative, creative mindset and a knack for self-motivated learning to the role. You will shape UNandUP’s commitment to quality as indispensable parts of effective product development – not simply a box to check. If you’ve ever brainstormed better ways to develop usable, compliant quality management system processes, this is the role for you.
Responsibilities
Qualifications
We encourage all interested applicants to apply, even if unsure whether all qualifications are met.
Benefits
This full-time, salaried role comes with a comprehensive benefits package including 401k and HSA plans; paid holidays and PTO; and medical, dental, and vision coverage for the employee and dependents. In addition, UNandUP encourages participation in professional development activities such as conferences, courses, and seminars. While this position is an in-person role, flexible work hours (e.g. for childcare pickup) are supported to the greatest extent possible.
UNandUP is an equal opportunity employer and does not discriminate based upon age, gender identity and expression, REDACTED orientation, race, ethnicity, religion, veteran status, socioeconomic status, or disability. All are welcome here.
To apply
Please submit a resume and cover letter listing contact information for one to two professional references to [email protected], listing the role “RQA Engineer” in the subject line.
About the role
UNandUP (Unmet Needs and Underserved Populations) LLC is a dynamic start-up company founded by established entrepreneurs to advance high-risk medical technologies from lab bench to clinic. We are seeking a passionate, motivated regulatory and quality engineer to join our growing team in St. Louis, Missouri.
RQA engineers design processes to foster effective, safe, and compliant development throughout the product life cycle; their work touches every stage of product evolution from preclinical prototyping to initial production. As core members of the team, RQA engineers work closely with engineers from varied disciplines to craft practical, efficient procedures and workflows that achieve 21 CFR 820 and ISO 13485 compliance.
The ideal candidate brings a collaborative, creative mindset and a knack for self-motivated learning to the role. You will shape UNandUP’s commitment to quality as indispensable parts of effective product development – not simply a box to check. If you’ve ever brainstormed better ways to develop usable, compliant quality management system processes, this is the role for you.
Responsibilities
- Learn. Keep in touch with the latest regulatory and quality requirements in the U.S. market for medical devices and pharmaceuticals; dive into new standards and guidances; explore practical, real-world systems for compliance.
- Collaborate. Understand the team’s current workflows for everyday product design, supplier management, purchasing, materials handling, and data storage. Identify compliance gaps and recognize top workflow needs.
- Triage. Assess compliance needs based on risk to identify top priorities for change.
- Create. Bring together your knowledge of existing workflows and quality/regulatory requirements to craft procedures that help every job function operate in compliance.
- Guide. Act as the team’s in-house touchpoint for all matters quality and regulatory, training colleagues, performing internal audits, and iteratively improving quality systems based on regulatory assessments and team needs.
- Embed. Manage document control, audit suppliers, develop verification and validation approaches, and lead risk assessments as the quality representative.
Qualifications
We encourage all interested applicants to apply, even if unsure whether all qualifications are met.
- 3+ years work experience in a regulated environment (e.g. healthcare, automotive, aerospace)
- Proven experience contributing to a quality management system
- History of implementing process improvements
- Excellent multidisciplinary collaboration skills
- Strong commitment to ethics
- Ability to thrive in a fast-paced, rapidly evolving environment
- Startup and pharmaceutical experience and AQA membership a plus
Benefits
This full-time, salaried role comes with a comprehensive benefits package including 401k and HSA plans; paid holidays and PTO; and medical, dental, and vision coverage for the employee and dependents. In addition, UNandUP encourages participation in professional development activities such as conferences, courses, and seminars. While this position is an in-person role, flexible work hours (e.g. for childcare pickup) are supported to the greatest extent possible.
UNandUP is an equal opportunity employer and does not discriminate based upon age, gender identity and expression, REDACTED orientation, race, ethnicity, religion, veteran status, socioeconomic status, or disability. All are welcome here.
To apply
Please submit a resume and cover letter listing contact information for one to two professional references to [email protected], listing the role “RQA Engineer” in the subject line.
