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).

　　JOB DETAILS:

　　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

　　QUALIFICATIONS:

　　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 the medical 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

　　Knowledge with 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 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

　　[email protected]

　　www.experis.com

　　ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.