Responsibilities :
- Develop QMS and overall Product Quality Methodology (i.e. product development process, tools / process such as FMEA, dFx, NPI, manufacturing, quality assurance).
- Develop and implement Quality Documentation Approach, Needs, and Gaps (SOPs, Policies, forms / templates, etc.)
- ISO 9001 Ready / Capable by roughly end of 2024.
- Support existing team members with training, reviewing existing processes, documents, capabilities, identify gaps / opportunities, recommend improvement or optimizations, and help develop a robust plan for short to long term QMS needs
Requirements :
- BS Degree minimum with 10+ years of industry experience.
- A blend of medical device and pharma experience is okay, but consultant must have strong medical device or diagnostic lab equipment experience.
- Prior experience conducting QMS implementations.
- Engineering background.
- This engagement will be limited to the Engineering side of our client's business and not the pharma side.
- Strong experience surrounding ISO 9001.
- Prior auditing experience with ISO 9001 is preferred but not required.
- Demonstrates strong understanding and ability to develop trainings, processes, and QMS related documentation.
Principal Prof, Clinical Quality Management Specialist - Fully remote / urgent need
Investigates quality trends, potential risks and mitigations with Quality Management leadership. Project Management - Leads medium-scale, may lead large Quality Management projects or programs with moderate risks and resource. Principal Professional, Quality Management. Performs complex analyses to ...
SAP Quality Management Specialist
Minimum 8 years of experience with progressive increase in responsibilities in Global Process Design, Deployment and/or support experience utilizing and configuring the SAP Production Planning, Quality Management, Plant Logistics (IM/WM) and Plant Maintenance modules with a heavy focus in Production...
Quality Management Specialist
Develop QMS and overall Product Quality Methodology (i. FMEA, dFx, NPI, manufacturing, quality assurance). Develop and implement Quality Documentation Approach, Needs, and Gaps (SOPs, Policies, forms/templates, etc. ...
Quality Management Specialist
Develop QMS and overall Product Quality Methodology ( product development process, tools/process such as FMEA, dFx, NPI, manufacturing, quality assurance). Develop and implement Quality Documentation Approach, Needs, and Gaps (SOPs, Policies, forms/templates, etc. ...
Quality Assurance Specialist
The Quality Assurance Specialist will play a significant role in the oversight and regulatory compliance of cell therapy manufacturing. Responsibilities for the Quality Assurance Specialist. Qualifications for the Quality Assurance Specialist. Compensation for the Quality Assurance Specialist. ...
Quality Assurance Specialist
The Quality Assurance Specialist is responsible for ensuring that products and services meet Quality standards and industry benchmarks. Staff Management Group is seeking a Quality Assurance Specialist for our client in Somerset, NJ. This role supports Quality Assurance processes, initiatives,R&D...
Quality Assurance Specialist (DDD)
The Quality Assurance Specialist will assist the Director of Quality Assurance with new program development and according to funding source guidelines and standards. We are a Behavioral Health Services company looking to add an experienced, conscientious and detail-oriented Quality Assurance Special...
Inventory and Quality Control Specialist
Inventory and Quality Control Specialist. Inventory Control & Fulfilment Team by performing the tasks necessary for the department to run smoothly and efficiently and ensure that we organize and control our highest dollar-value asset: inventory. Support on Quality control process as needed. At l...
Manager - Laboratory Quality Assurance
The Quality Manager will routinely report on the performance of the Quality System to senior leadership while maintaining and actively working towards improving the Quality System. Candidates in this position are responsible for leading a QA team, implementing the Quality System, and maintaining Qua...
Inventory and Quality Control Specialist
As an Inventory and Quality Control Specialist, you will support the Inventory Control & Fulfilment Team by performing the tasks necessary for the department to run smoothly and efficiently and ensure that we organize and control our highest dollar-value asset: inventory. Support on Quality cont...