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Plant Quality Management Representative - Medical Electronic Device Job
Date: Jul 30, 2010
Location: Elkton, MD, US
Plant Quality Management Representative - Medical Electronic Device-091487
Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, and electronics for more than 50 years.
As a leading medical products company, we are looking for a Plant Quality Assurance Management Representative to join our rapidly growing Medical Products Division and take on a broad range of responsibilities.
The ideal candidate will:
* Provide strong leadership and mentorship to Quality Assurance associates (and others) in our non-hierarchal structure.
* Be energized by working in a world-class manufacturing facility collaborating on cross-functional teams
* Recognize the importance of building and maintaining strong interpersonal relationships
* Demonstrate strong support for our unique culture
As a member of the plant operations leadership and Quality Assurance teams, your overall responsibilities will include the following:
* Function as the plant quality management representative for the Medical Electronic Devices (MED) portion of the plant
* Help lead the Quality Assurance function within the facility
* Help develop strategic QA resource plans
* Help lead and support the plant preparation and coordination for internal and external inspections
* Prioritize plant MED QA activities in alignment with Business Unit Leadership priorities
* Execute QA plans as outlined in the business plan and driving results
* Interact with Business Unit QA leadership
* Act as a Plant Representative for the Medical Division to ensure operational compliance
This position will also require that you engage the appropriate functional groups in communications and decisions and work with Business Unit(s) quality management representatives to help maintain a balanced perspective between plant and divisional impact, as appropriate. You will also help lead facility efforts to address product issues by providing direction to the implementation of effective corrective actions and reviewing the results of monitoring post-implementation effectiveness.
Additional Responsibilities include:
* Participate in design control and other activities in support of component manufacturing and new product development
* Systems enhancements including complaint system software implementation and validation
* Compliance auditing
* Work with procurement and engineering to select and approve vendors
* Work with engineering to enhance process yields
* Associate training
* Advisory roles supporting various teams (such as raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.)
* Initiate change documentation
* Prepare quality reports and presentations
* Review complaints
Qualifications
Required:
* Bachelor's degree in science or engineering or a two-year degree (preferably in engineering or science) plus significant medical device experience in a quality assurance role.
* 7+ years medical device or pharmaceutical industry experience in quality assurance
* 5+ years in a documented Quality Assurance leadership role
* Demonstrated track record of successful Quality Assurance leadership
* Demonstrated experience in successful partnership with other leadership functions (Business, Engineering, Manufacturing, and Regulatory)
* Experience leading US FDA and Notified Body facility inspections (or other similar regulatory body inspections)
* Strong interpersonal skills
* Understanding of design control
* Demonstrated ability to resolve conflict
* Quality systems implementation and maintenance (GMP/Quality System Regulations; ISO 9000/EN46000/ISO13485)
* Ability to multi-task and prioritize
* General understanding of statistics as applied to manufacturing
* Demonstrated excellent written and oral communication skills
* Vendor and process auditing (including certified auditor training) product/process/software validation
* Generation of change control documents
* Document control
* Receiving inspection
* Basic computer literacy
Highly Desirable Qualifications:
* Experience with PMA devices
* Experience with electronic and software controlled devices
Travel: 50% for the first 6 months and 25% thereafter
EEO/AA Employer (applies to all positions located in the U.S.)
Job
: Quality
Primary Location
: North America-United States-Maryland-Elkton
Travel
: Yes, 25% of the time
Shift
: Day (1st shift)
Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, and electronics for more than 50 years.
As a leading medical products company, we are looking for a Plant Quality Assurance Management Representative to join our rapidly growing Medical Products Division and take on a broad range of responsibilities.
The ideal candidate will:
* Provide strong leadership and mentorship to Quality Assurance associates (and others) in our non-hierarchal structure.
* Be energized by working in a world-class manufacturing facility collaborating on cross-functional teams
* Recognize the importance of building and maintaining strong interpersonal relationships
* Demonstrate strong support for our unique culture
As a member of the plant operations leadership and Quality Assurance teams, your overall responsibilities will include the following:
* Function as the plant quality management representative for the Medical Electronic Devices (MED) portion of the plant
* Help lead the Quality Assurance function within the facility
* Help develop strategic QA resource plans
* Help lead and support the plant preparation and coordination for internal and external inspections
* Prioritize plant MED QA activities in alignment with Business Unit Leadership priorities
* Execute QA plans as outlined in the business plan and driving results
* Interact with Business Unit QA leadership
* Act as a Plant Representative for the Medical Division to ensure operational compliance
This position will also require that you engage the appropriate functional groups in communications and decisions and work with Business Unit(s) quality management representatives to help maintain a balanced perspective between plant and divisional impact, as appropriate. You will also help lead facility efforts to address product issues by providing direction to the implementation of effective corrective actions and reviewing the results of monitoring post-implementation effectiveness.
Additional Responsibilities include:
* Participate in design control and other activities in support of component manufacturing and new product development
* Systems enhancements including complaint system software implementation and validation
* Compliance auditing
* Work with procurement and engineering to select and approve vendors
* Work with engineering to enhance process yields
* Associate training
* Advisory roles supporting various teams (such as raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.)
* Initiate change documentation
* Prepare quality reports and presentations
* Review complaints
Qualifications
Required:
* Bachelor's degree in science or engineering or a two-year degree (preferably in engineering or science) plus significant medical device experience in a quality assurance role.
* 7+ years medical device or pharmaceutical industry experience in quality assurance
* 5+ years in a documented Quality Assurance leadership role
* Demonstrated track record of successful Quality Assurance leadership
* Demonstrated experience in successful partnership with other leadership functions (Business, Engineering, Manufacturing, and Regulatory)
* Experience leading US FDA and Notified Body facility inspections (or other similar regulatory body inspections)
* Strong interpersonal skills
* Understanding of design control
* Demonstrated ability to resolve conflict
* Quality systems implementation and maintenance (GMP/Quality System Regulations; ISO 9000/EN46000/ISO13485)
* Ability to multi-task and prioritize
* General understanding of statistics as applied to manufacturing
* Demonstrated excellent written and oral communication skills
* Vendor and process auditing (including certified auditor training) product/process/software validation
* Generation of change control documents
* Document control
* Receiving inspection
* Basic computer literacy
Highly Desirable Qualifications:
* Experience with PMA devices
* Experience with electronic and software controlled devices
Travel: 50% for the first 6 months and 25% thereafter
EEO/AA Employer (applies to all positions located in the U.S.)
Job
: Quality
Primary Location
: North America-United States-Maryland-Elkton
Travel
: Yes, 25% of the time
Shift
: Day (1st shift)
Nearest Major Market: Philadelphia
Job Segments: Administrative, Compliance, Document Control, Electronics, Electronics Engineer, Engineer, Engineering, Facilities, Healthcare, Implementation Manager, Inspector, Law, Legal, Maintenance Engineer, Management, Manager, Manufacturing, Medical, Medical Device, Medical Research, Operations, Plant, Procurement, Product Development, QA, Quality, Quality Assurance, Research, Scientific, Technology
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