Senior Quality Engineer

Senior Quality Engineer

A leading global medical device company is HRIING a Sr. Quality Engineer with strong Medical Device industry Manufacturing and Quality Assurance experience to work within Manufacturing Execution System Team. Senior Quality Engineer is responsible for ensuring new MES (Manufacturing Execution System) deployments, sustaining, and/or optimization projects related to MES are implemented compliantly and in a timely manner. Sr. Quality Engineer required 6-8 years medical device industry experience including working knowledge of implementing and maintaining a Manufacturing Execution System / electronic device history record.

This is a Direct-hire position excellent compensation with competitive benefit package including Health, 401, PTO, FSA, Stock options, Yearly bonus,Sign-On Bonus, etc. No visa restriction (sponsorship program available) and company offer relocation assistance. Interested individuals are encouraged to contact or submit their CV to the following email address: [email protected] or call Rose Chu at 215-317-2999 for discussion.

SUMMARY:
Senior Quality Engineer, Manufacturing Execution System (MES)

• Ensure new MES deployments, sustaining, and/or optimization projects related to MES are implemented compliantly and in a timely manner; Support production to drive continuous improvement.
• Ensure compliance to quality policy, develop requirements, revise/create procedures, develop validation test cases, and maintain the integrity of the electronic device history record (eDHR).

• Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projects
• Demonstrates understanding and application of engineering principles on cross-functional projects
• Develop and/or revise MES requirements documentation, procedures, control plans, PFMEAs, and training materials
• Maintain the compliance of the MES, the integrity of its validated state, and the eDHR
• Proactively identifies requirements gaps, investigates, and implements best-in-class Quality Engineering practices and solutions
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MES
• Develop MES validation test cases and support Software Verification & Validation activities
• Support the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle Management
• Develop training strategy plans and support MES team to deliver training on MES processes

• Requires Bachelor's degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science or technical field with relevant experience
• Requires 6-8 years of Manufacturing and Quality Assurance experience in themedical device industry including some working knowledge of Manufacturing Execution System (MES)
• Experience with implementation and sustaining required.
• Experience with CSV (software validation) required.
• Experience working in a manufacturing environment required
• Knowledgewith MES (Manufacturing Execution System), CAMSTAR and MES Software, FactoryWorks.
• Experience with implementing and maintaining a Manufacturing Execution System / eDHR preferred
• Experience with Change Management, and HP ALM 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
• Excellent computer skills and working knowledge of Microsoft Office Suite

Please forward your credentials in Word format by email your resume directly to [email protected]
or call Rose Chu direct at215-317-2999 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
[email protected]
www.experis.com