Medical Device QA Consultant (REF8198U)

Medical Device QA Consultant (REF8198U)

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Job Description

This Medical Device QA Consultant is responsible for guiding a medical device component project that is in late stages before PV and commercialization.

Essential Functions Include:

• Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO 13485:2016 and ISO 9001:2015 requirements.
• Lead the site ISO 13485:2016 certification.
• Lead Risk Management program.
• Provide direct Quality support for CAPA/Deviations/Change Control, DFMEA, PFMEA and residual risk analysis, etc.
• Assist in the development of appropriate statistical measurements.
• Support customer Audits, certification Audits, and Complaint handling.
• Support internal and external customer Quality requests with timely follow up and participation in new business development projects.
• Review product life-cycle documents and deliverables, e.g., reports, SOPs, studies, protocols, batch records, etc.
• Provide Compliance and Quality guidance for Process and Cleaning Validation.
• Drive establishment of proper controls and sampling for development and manufacturing activities.
• Perform data trending.
• Lead medical device Change Control activities.
• Provide Compliance and Quality Guidance for Design Verification, Design Validation, Shelf Life Stability Studies, Simulated Distribution Studies, Feasibility Studies, and Test Method Validations.
• Lead medical device Supplier Quality activities.

Qualifications

Qualified candidates must have:

• Required: BS/BA in a scientific discipline.
• Preferred: Graduate degree in a scientific discipline.
• 10 years’ quality management experience.
• Quality orientation and high attention to detail.
• Demonstrated ability to lead people and get results through others.
• Strong working knowledge of cGMP regulations, USP standards, and ICH and FDA guidance documents.
• Ability to interact in a professional and positive manner with clients and co-workers.
• Strong editorial skills for the review and approval of GMP documentation, including protocols, reports, SOPs, design history files, etc.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• Ability to manage and work with multiple individuals (where applicable); in company quality program and compliance-related activities.
• Ability to manage and execute multiple tasks associated within the compliance, quality assurance, and validation fields.
• Exceptional communicator with strong persuasion skills and presentations.
• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Proven record with team leadership, problem-solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.
• Experience creating and working with high-performance teams.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• Ability to think ahead and prepare action plans to achieve results.
• Supervisory experience, including employee hiring and retention, performance review and discipline.
• Ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Excellent analytical skills and the ability to access and resolve difficult business situations.
• Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift reasonable weights (approximately 35 lbs.), read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
• Understanding ofdesign control process for medical devices

Additional Information

• All candidates must be legally eligible to work in the United States.
• We are an equal opportunity employer. M/F/D/V
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.