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Project Management Specialist

In Pennsylvania / United States

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Project Management Specialist   

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JOB TITLE:
Project Management Specialist
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Zelienople Pennsylvania / United States

JOB DESCRIPTION :

Job Description: -

  • The Supplier Quality Engineer is accountable supplier/vendor selection, qualification, and approval, as well as supplier process qualifications, monitoring supplier's, and supplier corrective action requests.
  • This position will have direct interaction with the Procurement, Division R&D, Manufacturing, Service, and Manufacturing Engineering groups to support new product introduction, continuous improvement, and manufacturing sustaining activities.
  • The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.
  • An understanding of the application of quality standards and regulations (21CFR 820, ISO-13485) is necessary.

Roles and Responsibilities: -

  • Provides focused supplier quality engineering support and assumes responsibility for timely and effective coordination and/or execution of assigned project activities.
  • Acts as an effective team member in supporting quality discipline, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving supplier quality issues.
  • Track's supplier quality trends and initiates supplier corrective actions to resolve issues.
  • Manages assigned corrective actions and drives them to closure.
  • Trends, analyzes, and reports on quality data to improve products and processes.

Education and Experience: -

  • BS in Electronics, Electrical, Mechanical, Bio-Medical, etc. required.
  • 2+ years' experience in Medical Device manufacturing or similarly regulated industry required.
  • Proven ability to develop and/or approve supplier PFMEAs, Control Plans, Measurement System Analysis, Special Process Validation, FAI, Routine Lot Acceptance activities is required.
  • Experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) required.
  • Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills required.
  • Ability to understand, plan, and execute supplier qualification activities required.
  • Demonstrated strong attention to detail and "do it right the first time" attitude required.
  • Good judgment and decision-making skills are required; knows how to make trade-off decisions while balancing compliance and business impact required.
  • Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required.
  • Ability to travel up to 30% is required.
  • Basic knowledge of electro-mechanical devices preferred.
  • ASQ Certified Supplier Quality Engineer, ASQ Certified Quality Auditor, or equivalent preferred.
  • Familiarity with ISO14971 and associated Risk Management Processes preferred.
  • Three to five years of experience in a medical device quality assurance environment preferred.
  • One to two years of auditing experience preferred.

Position Details

S16174661706153750
Pennsylvania / United States
Zelienople
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Project Management Specialist    Apply

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Job Description: -

  • The Supplier Quality Engineer is accountable supplier/vendor selection, qualification, and approval, as well as supplier process qualifications, monitoring supplier's, and supplier corrective action requests.
  • This position will have direct interaction with the Procurement, Division R&D, Manufacturing, Service, and Manufacturing Engineering groups to support new product introduction, continuous improvement, and manufacturing sustaining activities.
  • The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.
  • An understanding of the application of quality standards and regulations (21CFR 820, ISO-13485) is necessary.

Roles and Responsibilities: -

  • Provides focused supplier quality engineering support and assumes responsibility for timely and effective coordination and/or execution of assigned project activities.
  • Acts as an effective team member in supporting quality discipline, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving supplier quality issues.
  • Track's supplier quality trends and initiates supplier corrective actions to resolve issues.
  • Manages assigned corrective actions and drives them to closure.
  • Trends, analyzes, and reports on quality data to improve products and processes.

Education and Experience: -

  • BS in Electronics, Electrical, Mechanical, Bio-Medical, etc. required.
  • 2+ years' experience in Medical Device manufacturing or similarly regulated industry required.
  • Proven ability to develop and/or approve supplier PFMEAs, Control Plans, Measurement System Analysis, Special Process Validation, FAI, Routine Lot Acceptance activities is required.
  • Experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) required.
  • Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills required.
  • Ability to understand, plan, and execute supplier qualification activities required.
  • Demonstrated strong attention to detail and "do it right the first time" attitude required.
  • Good judgment and decision-making skills are required; knows how to make trade-off decisions while balancing compliance and business impact required.
  • Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required.
  • Ability to travel up to 30% is required.
  • Basic knowledge of electro-mechanical devices preferred.
  • ASQ Certified Supplier Quality Engineer, ASQ Certified Quality Auditor, or equivalent preferred.
  • Familiarity with ISO14971 and associated Risk Management Processes preferred.
  • Three to five years of experience in a medical device quality assurance environment preferred.
  • One to two years of auditing experience preferred.