GForce Life Sciences · 10 hours ago
Remote, Sr Quality Validation Engineer, Medical Devices, Consultant
United States
Contract
Remote
Senior LevelGForce Life Sciences is a growing medical device manufacturer, and they are seeking a Quality/Process Validation Engineer to join their team. This individual will perform process validations and qualifications of new/existing equipment and processes in a medical device environment, focusing on documenting processes and equipment to meet current regulatory standards.
ConsultingProject ManagementRecruiting
Responsibilities
The Process Validation Engineer will provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing process controls
Communicates current and applicable good manufacturing practices (GMP) (e.g.: ISO13485 / 21 CFR Part 820 / CMDR) to business partners
Executes functions needed to support change control activities and document management requirements
Collaborates with business partners and peers to define validation and change control activity requirements for individual projects
Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on
Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability/reliability
Leads / participates in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA)
Writes/revises or reviews /approves a variety of validation lifecycle documents
Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), sterilization, process validation, cleaning validations, packaging validation, distribution validations, requirement specifications, method validations, SOPs, work instructions, and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports
Supports the delivery of system solutions by assuring validation activities are conducted in a compliant but cost-effective manner
Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations
Performs investigations and troubleshoots validation problems for equipment, performance process and system, and so on
Audits the compliance of validation activities and assists during internal/external audits
Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities
Proactively identifies and resolves issues, and escalates concerns as appropriate
Ensures corrective actions are completed in a timely manner
Promotes continuous improvement by ensuring adherence to quality principles
Seeks out and actively participates in business initiatives that contribute to service excellence
Collaborates and teams with Laboratory, Quality and Validation Engineering, LIMS, and project management personnel
Qualification
Required
Experience in Quality, Regulatory and/or Compliance within the medical device
A strong background in validation (and statistical tools such as Sampling Plans, Experimental Design, and Optimization) is required
Knowledge of current and applicable GMP regulations is required
Experience with high volume molding manufacturing experience
Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required
Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required
Preferred
Knowledge or experience with quality audits is preferred
Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred
ASQ Certification or equivalent is preferred but not mandatory
Company
GForce Life Sciences
GForce Life Sciences is a platform for career management that offers executive search, medical affairs consulting, and project management.
Founded in 2013
51-200 employees
H1B Sponsorship
GForce Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Mark Gallagher
Founder & CEO
Company data provided by crunchbase