Quality Engineer II

A leading global medical device company is looking for a Quality Engineer II to start ASAP. Quality Engineer required to work in Elkton, MD (Flex time/Flex day). This is a Direct-Hire opportunity (NO sponsorship) with EXCELLENT benefit page including relocation assistance and sign-on bonus. Interested individuals are encouraged to contact or submit their CV to the following email address: or call Rose Chu at 215-317-2999 for discussion.
Summary:

• The Quality Engineer II position will work closely with the Operations and Engineering Team to ensure that goods are designed, developed , and made to meet or exceed our customer expectations and requirements.
• The position will support production and project activities and drive continuous improvement. Ensure compliance to quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

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.

Qualifications:

• 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.
• Experience working in a manufacturing environment preferred
• One year of auditor experience preferred
• Certification as a CQA; CQE or CQM and member of the ASQ is preferred
• 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

Please forward your credentials in Word format by email your resume directly to
or call Rose Chu direct at 215-317-2999 for questions. Our technical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.
Rose Chu
Pharma, CRO and Medical Device Service
Experis
C: 215-317-2999