Job Title: Supplier Quality Engineer Job Function: Quality Consultant Location: Bothell, WA
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
USDM is looking for an experienced Supplier Quality Engineer to join our team. The Supplier Quality Engineer will perform supplier quality activities in the SQE team related to, for example, purchased part qualification with suppliers (APQP), supplier quality issue resolution (QN, SCAR), and ensuring appropriate incoming material inspection strategies.
Perform Supplier Quality activities in the SQE team related to, as example, purchased part qualification with suppliers (APQP), supplier quality issue resolution (QN, SCAR) and ensuring appropriate incoming material inspection strategies.
Drive quality activities with suppliers, setting a high standard and fast response expectation to solve issues and control and prevent.
Collaborate across functional areas of amongst others R&D, Manufacturing, Procurement and lead with best practices to enable our organization to provide high quality medical products to our customers.
Manage Supplier Quality related activities for purchased materials.
Work with suppliers to ensure all necessary quality activities are rigorously addressed during initial product release and change such as: process mapping, process FMEA, process control plan, process validation (IQ, OQ, PQ), GR&R, MSA, line release, etc.
Ensure supplier test strategy aligns with quality goals.
Focus on quality issue resolution via a Supplier Corrective Action request process.
Resolve quality issues via structured quality methods in order to ensure efficient and effective root cause analysis, and corrective / preventive actions that ensure there is no recurrence.
Execute supplier audits, CAPA's and monitor supplier metrics. Orchestrate first article inspection / first production inspection, and ongoing inspection plans that are aligned with supplier's capabilities, quality history and our product needs. Support key processes as subject matter expert.
High level knowledge of the regulations: 21 CFR 820, ISO 13485 and ISO 14971.
Strong APQP background, SQE experience and someone with a questioning attitude, able to prioritize and execute tasks in a dynamic environment, will excel in this role.
Experience with all aspects of supplier quality management: quality concepts/tools/methods (e.g. APQP / PPA / PSW, FMEA, DOE, IQ/OQ/PQ, TMV / MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures.
Expert working knowledge of standards and regulations applicable to supplier controls affecting a medical device.
Requires strong working knowledge of quality assurance principles and practices, industry and international safety standards.
Must possess excellent communication (verbal & written) skills.
Must practice analytical problem-solving skills.
Working knowledge of various software packages including Microsoft (Excel, Word, Project, and SharePoint).
Knowledge of implementing testing frameworks.
Highly organized with efficient use of time.
Ability to facilitate collaboration with cross-functional groups development in a team environment.
Education & Certifications
B.S. in engineering or an alternative bachelor's degree program with certification as a quality engineer (e.g. CQE) plus 3 years' experience in a Quality Engineering role, or an equivalent combination of education and experience.
Certified Quality Engineer (CQE) preferred.
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.
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.
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.
Base salary/hourly rate (W2): USD 50.00 - 60.00
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: