*This is Neha from Apetan consulting,*

*Please find the below job description and send me your update resume
matching to it along with Contact details, Current location, Visa and
Availability ASAP.*


* INTERVIEW: Phone than F2F Interview*

*LOCATION: Caledonia, MI*



*Job Overview:*

*Need candidates with heavy manufacturing experience .  Key experience will
be FDA, ISO and Regulatory experience*

*Must have experience with Medical Devices & have a Bachelors Degree in
Engineering.  No exceptions.*

·         Supports validation and risk build activities with manufacturing
and engineering group

·         Leads Customer Complaint Investigations

·         Responsible for customer complaint product dispositions

·         Performs root cause analysis and implements effective corrective
action for customer complaints and CAPA’s

·         Assess quality performance using statistical and analytical

·         Initiates non-conforming dispositions

·         Initiates CR’s and CO’s

·         Develops and implements test methods and procedures for
inspecting, testing and evaluating product and processes

·         Develops gauging methodology for products

·         Performs capability studies and gage R&R

·         Reviews and approve calibration records

·         Continuously identifies areas of improvement in the manufacturing
processes that would enhance product quality and partner with manufacturing
to implement the improvements

·         Conducts trend analysis: collect data, create, update & maintain
trend charts and reports

·         Analyzes improvement opportunities through MRB monitoring

·         Supports Quality Improvement Coordinators to ensure products &
processes comply with regulatory and QSM requirements

·         Develops trainings to build quality awareness

·         Reviews and approves risk management/risk analysis documents

·         Participates in PFMEA and DFMEA reviews

·         Participates and provides input in design review meetings,
partnering with NPD and Manufacturing during the entire development and
transfer process

·         Supports manufacturing and engineering to resolve technical issues


·         Bachelor’s degree in Engineering or a technical field preferred

·         3+ years of experience responsible for Quality improvement
projects preferred

·         2+ years of experience in a regulated industry experience that
includes FDA and ISO requirements preferred

·         ASQ certification a plus

·         Communication – displays developed interpersonal skills:
leadership, team orientation, ability to communicate at all levels

·         Flexibility and Adaptability – make effective decisions and
maintain effectiveness under changing circumstances and priorities

·         Teamwork, communication, positive attitude required to support
the manufacturing environment

·         Ability to read and analyze technical prints and drawings

·         Problem Solving – able to perform root cause analysis and
implement effective corrective actions

·         Project Management – able to effectively manage and complete
multiple projects simultaneously

·         Conduct Process Failure Mode and Effect Analysis (PFMEA)

·         Experience in 3D modeling, “Solidworks” preferred

·         Computer Skills – Excellent computer skills including but not
limited to Microsoft Office Suite


·         Knowledge of quality system including the quality manual, quality
policy and applicable procedures and work instructions

·         Establish, implement, and maintain the quality system in
accordance to FDA Quality System Regulation, ISO 13485, European Union
Medical Device Directives, and Canadian Medical Device Regulations


*Neha Kumari |* *Technical Recruiter* | *Apetan Consulting LLC*

Tel:201-620-9700* 106 | Fax: 201-526-6869 | 72 Van

Reipen Avenue # 255 Jersey City, NJ 07306 |

n...@apetan.com | www.apetan.com  |

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