Duration
- 6 months, contract to perm option.
Location
- 3 days onsite in MA or MD
Start Date
- Targeting July 29th or August 5th
Job Description
- Our medical device client is currently seeking an Internal Lead Quality Auditor to assist with initiation of the company’s internal auditing program. The auditing program is at the inception-stage where the resource coming in would be responsible for establishing the internal auditing programs’ efforts, implement training tools, setting up auditing checklists, facilitating supplier audits, writing reports, setting up auditing schedule, present to executive leadership, author SOP’s, etc. There will be heavy cross-functional collaboration with the R&D & Quality Groups as well as other suppliers in which extensive guidance from the Lead Quality Auditor will be expected for this project. Must come from quality, previously software, possibly programming or coding experience previously. FDA, BSI, TÜV SÜD, DEKA audits, ISO 62304, 62366, 60601, 13485, EU MDR and regulatory audits.
- Candidates considered for this project must be comfortable in being considered a ‘driver’ for this project. There will be minimal-to-no supervision provided therefore displaying strong/effective communication is highly critical. Working at a high-volume and fast-paced environment while establishing an entire internal quality auditing program will require emotional intelligence and problem-solving skills. This role requires someone with excellent judgement and the ability to make sound decisions in challenging situations with an ability to adapt quickly.
- Someone who has been an Quality Manager for Software Projects with a proven background of internal quality auditing programs is ideal for this role. During the interview, candidates will be asked what software products they have worked on and what specifically was done in regards to those projects. If someone says they did FMEA work.. manager will wants to identify if it was the software FMEA as opposed to the design FMEA work. Understanding the full software development lifecycle is mandatory. Experience with SaMD highly preferred.
- Required (must haves): Medical Devices (class I-III), Demonstrated background as an Internal Lead Auditor, Remediation/483 experience, Software Product Lifecycle, understanding nuisances of software, strong leadership skills
Skills
- SaMD, IEC 62304 / 62366 / 60601, ISO 13485 /14971, Internal Quality / Regulatory Audits, Supplier Audits, Lead Auditor, Medical Devices, Quality
Bonus (nice to have)
- Worked with companies such as Medtronic, Becton Dickinson, Boston Scientific, implantable devices
Education
- Degreed engineer and preference for auditor certification.
Hybrid in Greater Boston: Lead Auditor / Quality Manager- Evinova Division (235190)
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