Sr. Quality Consultant

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

The Medical Device Quality Specialist will lead consulting projects for clients in the medical device, pharma and biotech industries. You will be responsible for ensuring the quality and compliance of medical devices that use software, AI/ML, or other innovative technologies. You will also advise clients on software in or as a medical device development and compliance, and agile software development. You will work with a team of multidisciplinary professionals who have extensive experience in medical device quality, software, and regulatory affairs.

Primary Responsibilities

• Plan, execute, and oversee quality activities for medical device projects, including risk management, design control, verification and validation, and post-market surveillance.
• Write, review and/or approve quality documents, such as quality plans, protocols, reports, procedures, and records.
• Ensure compliance with ISO 13485, 21CFR Part 820, 21 CFR Part 11, EU MDR/IVDR, and other applicable US and EU medical device regulations and standards.
• Provide guidance and support to clients on software in or as a medical device, AI/ML for medical devices, and agile software development.
• Provide thought leadership and guidance to customers on AI/ML in medical device product software
• Communicate with clients, stakeholders, and regulatory authorities on quality and regulatory matters.
• Lead and manage project teams, timelines, and deliverables.
• Identify and resolve quality issues and risks.
• Conduct audits and inspections of medical device processes and products.
• Provide training and coaching to clients and team members on quality and regulatory topics.

Qualifications

• At least 10 years of experience in medical device quality, software, or regulatory affairs.
• Strong knowledge of software in Medical Devices and Software as a Medical Device, AI/ML for medical devices, and agile software development.
• Expertise in ISO 13485, 21CFR Part 820, 21 CFR Part 11 EU MDR and other applicable US and EU medical device regulations and standards.
• Familiarity with FD&C 524B, ensuring Cybersecurity of Devices and the associated Quality System, guidance.
• Computerized Systems design controls and validation, according to traditional CSV and CSA approaches
• Excellent communication, presentation, and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Problem-solving, analytical, and critical thinking skills.
• Nice to have: Invitro Diagnostics Regulations Exposure
• Quality certifications in GCP, GMP, GLP, GMLP, Regulatory Certifications (eg RAC) and ISO Certifications all positive
• Equivalent EU experience a big plus

Education & Certifications

• Bachelor’s degree or a University Certificate or Degree in technology or related field. Masters or PhD a plus.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.

• Operate other office productivity machinery, such as a calculator, scanner, or printer.

• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

• Travel to client site for onsite work as needed.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

COMPENSATION

Salary/Hourly Rate Range (W2): USD 65.00 - 120.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers