We are seeking qualified compliance, quality, and regulatory affairs professionals to join our consulting team. See the types of consulting roles we are actively searching for below.

Consulting Opportunities


QMS Validation Manager

(9-mo contract opportunity in Seattle-metro area)

In this role, you have the opportunity to help build a high growth business that will help improve the lives of millions of people while advancing Client’s journey as a global leader in Health Technology.

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Supplier Quality Engineer

(9-mo contract opportunity in Seattle-metro area)

Perform Supplier Quality activities related to purchased part qualification with suppliers, supplier quality issue resolution and ensuring appropriate incoming material inspection strategies. Drive quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized. Lead with best practices to enable our organization to provide high quality medical products to our customers.

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CAPA/Quality Engineer - Generalist

(9-mo contract opportunity in Seattle-metro area)

The CAPA/Quality Engineer (QE) is responsible in developing and implementing systems to ensure products are designed and produced to meet customer requirements and expectations. He/she drives the strategy and approach of the CAPA team to establish the root cause in a systematic way and coordinates the use of adequate tools and methods. Provides direction for the cross-functional team with other business and engineering disciplines to follow a structured problem solving approach. Establishes the principles of product and service quality evaluation and control for the system. Provides independent oversight and review of the project deliverables throughout the product lifecycle. Provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same.

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Regulatory Affairs Consultant II / Regulatory Affairs Specialist

(9-mo contract opportunity in Seattle-metro area)

The Regulatory Specialist will provide timely and valued regulatory guidance (written and or verbal) by owning the following tasks such as advising internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives, and more.

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CAPA/Quality Engineer - Design Controls/Risk Management

(9-mo contract opportunity in Seattle-metro area)

The CAPA/Quality Engineer (QE) is responsible in developing and implementing systems to ensure products are designed and produced to meet customer requirements and expectations. He/she drives the strategy and approach of the CAPA team to establish the root cause in a systematic way and coordinates the use of adequate tools and methods. Provides direction for the cross-functional team with other business and engineering disciplines to follow a structured problem solving approach. Establishes the principles of product and service quality evaluation and control for the system. Provides independent oversight and review of the project deliverables throughout the product lifecycle. Provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same.

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Systems Engineer

(9-mo contract opportunity in Seattle-metro area)

Client’s Emergency Care and Resuscitation business unit is looking for a Senior Individual contributor. In this position, you will be the technical leader for product improvement and enhancements of a major product line within the ECR portfolio. You will be a problem solver on cross functional technical issues, own the product from concept, through development of the customer requirements, product architecture, systems requirements and allocation of requirements to subsystems and components. You will work collaboratively with the technical cross functional team for the product as well as directly with system V&V resources to ensure that the product meets both the requirements and customer expectations for life saving and life sustaining devices that are used in hospitals and pre-hospital situations globally. 

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V&V Electrical Engineer

(9-mo contract opportunity in Seattle-metro area)

Key responsibilities include supporting product verification through development, manufacturing and into continuation providing technical support and leadership on a cross-functional team, as well as defining, documenting, and continuously improving verification tests including conducting peer reviews and maintaining traceability to requirements, and more. 

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V&V Mechanical Engineer

(9-mo contract opportunity in Seattle-metro area)

Key responsibilities include supporting product verification through development, manufacturing and into continuation providing technical support and leadership on a cross-functional team, as well as defining, documenting, and continuously improving verification tests including conducting peer reviews and maintaining traceability to requirements, and more. 

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Reliability Engineer

(9-mo contract opportunity in Seattle-metro area)

Key responsibilities include working hand in hand with the program manager, product manager and cross functional leads to ensure the overall product/solution system integrity from concept to end of life of the product, including meeting all expectations from major stake holders like manufacturing, quality, regulatory bodies and reliability in addition to customer and patients, and more. 

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Medical Device Single Audit Program (MDSAP) and ISO 13485:2016 Auditor

We are looking for experienced professionals with the skills, knowledge, training and, preferably, certification to assess quality systems against MDSAP and its associated national regulations and/or ISO 13485:2016.

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International GxP Auditor

We are looking for qualified individuals based outside the US with skills, knowledge, and experience to lead and/or participate in global GxP auditing including GMP, GCP, GLP, pharmacovigilance (PV), and/or data integrity/Part 11/Annex 11. Internal audits/inspection readiness as well as assessments of suppliers should be expected.

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Former FDA Employees

We are looking for former (and soon-to-be former) employees of US FDA who are interested in consulting opportunities in the private sector.

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