Supplier and Third Party Distributor Quality Engineer Consultant

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The Supplier and Third Party Distributor (TPD) Quality Engineer is involved in supplier and TPD qualification and monitoring of quality, as well as Internal Audit activities, as required.

Responsibilities:

• Lead Supplier, TPD, and Internal audits/monitoring including pre-audit research, planning/coordination, report writing, and audit finding follow up.
• Qualify new suppliers and TPDs
• Evaluate supplier change requests
• Generate Supplier and TPD Corrective Action Requests (SCARs/TCARs) including issuance, evaluation, and effectiveness monitoring as required and follow up with Suppliers for completion/closure
• Monitor quality performance of suppliers/TPDs
• Negotiate quality agreement terms
• Act as liaison between suppliers, engineering, and manufacturing
• Execute Internal Audit activities, including pre-audit research, planning/coordination, report writing, and audit finding issuance. 

Requirements:

• Bachelor's degree in a technical discipline
• Knowledge of medical device regulations, pertinent standards and guidance's
• 5 years of Supplier Quality experience preferred
• Auditor certification (ASQ or equivalent) is required
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality standards
• Must have effective oral and written communication skills
• Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situation
• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Travel up to 15%

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

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