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 growthOur deep domain knowledge and technology expertise in life sciences business processes are what sets us apartFrom 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 moreFrom 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 clientsAre 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
Usdm is looking for a remote-based design quality engineer for our client.
Primary responsibilities
Lead and manage review and approval of sdlc deliverables in accordance with software as medical device and design controls procedures.
Review and approve plans, requirements, protocols and reports generated as part of the software development processDetermine and enforce quality and safety requirements in accordance with company needs and ensure compliance to design control procedures.
Represent device quality on cross-functional teams in support of sdlc activities.
Act as subject matter expert in developing and revising validation documents ensuring compliance with regulatory requirements.
Lead and facilitate risk assessment (design (system) fmea) and mitigationReview and approve risk management documents.
Provide guidance and support to device development/testing team in their verification (system, uat) and validation (human factors formative study) efforts, to ensure compliance.
Review and approval of adjudicated issues (e.gDeviation, investigations) and technical matters (e.gDesign changes, verification and validation) with impact to design control and risk management.
Qualifications
Proficiency in system development lifecycle activities and documentation.
Either experience in software development activities and or computer system validation.
Experience in iso 13485 and iec 62304.
Fda 21 cfr part 820 with good understanding of quality system, tools and practices.
Education
Bs/ba degree in related discipline and four years of related experience.
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 inclusiveReasonable 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 messageMust be able to exchange accurate information in these situations.
Equal opportunity statement
Usdm life sciences is an equal opportunity employerAll 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 positionIt is not intended to include every job duty and responsibility specific to the positionUsdm life sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
