Jobs

Project Manager and Quality System Manager - Home Based

Medical/Pharmaceutical - Quality
Ref: 448 Date Posted: Friday 10 Sep 2021
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Our Client

Our client is a company that have created a Vascular Expert software, which gives excellent health care by providing useful, actionable information. Their Vascular Expert system allows you to understand a person’s vascular health through a physiological response to blood flow, also known as a Doppler waveform.

Job Summary

Project management duties include oversight of the day-to-day project coordination and oversight for the clients business and Quality Management System.  Must acquire in-depth knowledge of medical device commercialization and company standard operating procedures. Create workflows, procedures, and design site specific tools to enhance efficiency and accuracy in completing business and operational tasks.

Quality system management responsibilities include:

  • Maintenance of quality programs, systems, processes and procedures to ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. 
  • Lead the management and oversight of Quality System tools, systems, and training programs. 
  • Partners with subject matter experts to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data, and other documented requirements for quality objectives. 
  • Review and approve product related study protocols, data, records, and reports. 
  • Oversee production of products to ensure manufacturing and analytical testing are performed in accordance with applicable company procedures and comply with all applicable regulatory requirements. 
  • Provide QA approvals for change notices, test methods, and test equipment to assure the design and production of products are in compliance with applicable standards. 
  • Drive corrective action investigations implementation, and verification activities. 
  • Participates in new product development to identify, apply, and update quality document for compliance with standards or regulatory requirements as it pertains to product design, manufacture, and labeling. 
  • Supports the filing of the clients regulatory filings, distribution control database, adverse event reporting, complaints, and returns. 
  • Support regulatory inspections and third part audits.  Required to work with diverse populations of people from vendors and consultants to consumers.

The Project Manager will work under the direction of the Managing Director.  Also responsible for allocation of personnel and/or vendor resources across various projects.  This individual must have the ability to work collaboratively with internal and external teams.  General level of knowledge of project management, medical devices, business operation, clinical research, decision-making, and analytical skills. Strong verbal, written, and interpersonal communication skills.

Responsibilities

  • Monitor product manufacturing and quality system processes for compliance with company and regulatory quality management.
  • Adheres to quality management processes and practices. Analyzes patterns and identifies key areas for improvement of processes or results.
  • Applies key aspects of continuous improvement processes and evaluates impact on quality
  • Develops and monitors ongoing techniques for assessing the quality of product manufacturing.
  • Maintains current certifications in specialty and continues education when necessary
  • Works with quality assurance methods, tools and techniques.
  • Assists in detailed project plans including cost, schedule, and resource requirements.

Education/Experience

  • Bachelor’s Degree required in STEM (Science, Technology, Engineering, and Math) field.
  • Minimum of 3 years’ related work experience required working in the Medical Device industry and an ISO 13485 - Quality System. Thorough knowledge of applicable regulatory rules and guidelines e.g., ISO 13485, cGMP, ICH, GCP, GLP, SOPs strongly preferred.
  • Valid driver’s license

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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