Quality Engineer II

Must Have

Job Responsibilities

·         Engineering degree with minimum 4-6 years of relevant quality engineering experience and overall 4+ years of experience

·         Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

·         Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.

·          Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs

·          Participate with cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, risk management report,PMS Plan & related deliverables for EU-MDR).

·          Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.

·          Provide guidance and direction for sample size and statistical analysis of verification and validation test results.

·          Review Design History Files and Technical Files for conformance to applicable requirements

·          Participate and provide input to training on department / division procedures and policies

·          Participate when appropriate in internal and supplier audits.

·          Provide Quality support to facilitate resolution of product complaints and/or safety issues

·         Provide support to the Regulatory Department in writing technical submissions.

Minimum Qualifications

·         Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.

·         Good verbal and written communication skills including protocol / report development and technical presentations.

·         Risk Management - ISO 14971

·         Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.

·         Test plan development and root cause failure analysis.

·         Previous experience working in a cross-functional team environment.

·         Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO

·         Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.

·         Familiar with IEC 60601 and product specific industry standards.

Nice to Haves

·         ASQ CQE, CQA, CSQE and/or CRE certification.

·         13485 lnternal/Lead Auditor Certification

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.