Experis · 3 days ago

Quality Engineer II

Elkton, MD

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.

Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Acts as an effective project lead or team member in supporting quality disciplines, decisions, and practices.

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Identify non-conformance trends and develop technical investigation plans. Investigates and analyzes customer/internal complaints.

Performs data analysis and executes experiments to qualify or resolve product and process issues.

Creates, reviews, and approves internal documentation such as quality plans and standard operating procedures.

Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

Responsible for developing and implementing master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.

Qualification

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Quality System RegulationsISO 14971ISO 13485MDD 93/42/EECMedical Device RegulationsCanadian Medical Device RegulationsManufacturingAuditorCQACQECQMASQ

Required

Bachelors degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science, mathematics, or physics

Requires 3-8 years experience in a medical device or highly regulated industry

Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC