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QA Engineer II - Medical Device (Full-time & Permanent)

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Company: Coyote Technical & Executive Sourcing

Location: Felton, DE

Date Posted: April 24, 2014

Source: Coyote Technical & Executive Sourcing

QA Engineer II

Job Summary:

The management of the divisional complaint handling system to ensure compliance to FDA, Canadian, European and Divisional reporting regulations and procedures. The incumbent will coordinate and co-lead with the Director of Quality, the divisional Product Surveillance Committee to ensure the appropriate complaint trends and serious complaints are readily identified, corrective and preventative measures established to preclude reoccurrence and initiate appropriate regulatory reporting and/or field corrective actions.

Performing the duties and responsibilities described within Quality System documentation for the Divisional DCO.

The leadership of projects or teams to improve Quality systems or other systems and functions within the division.

Essential Duties:

Provide leadership and supervision of Customer Quality to ensure timely and accurate input of data and administrative duties.
Responsible and accountable for assuring full compliance for compliant and reporting management to US FDA Medical Devices and Drugs (Adverse Event Reporting) requirements, EU Vigilance reporting ...

QA Engineer II

Job Summary:

The management of the divisional complaint handling system to ensure compliance to FDA, Canadian, European and Divisional reporting regulations and procedures. The incumbent will coordinate and co-lead with the Director of Quality, the divisional Product Surveillance Committee to ensure the appropriate complaint trends and serious complaints are readily identified, corrective and preventative measures established to preclude reoccurrence and initiate appropriate regulatory reporting and/or field corrective actions.

Performing the duties and responsibilities described within Quality System documentation for the Divisional DCO.

The leadership of projects or teams to improve Quality systems or other systems and functions within the division.

Essential Duties:

Provide leadership and supervision of Customer Quality to ensure timely and accurate input of data and administrative duties.
Responsible and accountable for assuring full compliance for compliant and reporting management to US FDA Medical Devices and Drugs (Adverse Event Reporting) requirements, EU Vigilance reporting and all other applicable international complaint reporting requirements.
As required, interfaces directly (verbally and written) with customers to resolve issues and help ensure complete customer satisfaction.
Monitors methods and procedures for continuous customer satisfaction.
Leads divisional Product Surveillance Committee (monthly and weekly Special Product Surveillance Committee).
Generates monthly complaint summary reports and analysis for both corporate and divisional leadership.
As required, initiates and develops Health Hazard Evaluations (HHEs), based on potential product risk issues.
Assists in development, implementation, and monitoring of various reporting systems concerning product returns, performance and quality to assist top management in problem resolution and product decision making.
Identifies quality issues, develops and performs trend analysis on corrective and preventive actions through coordinated efforts with QC, R&D and Manufacturing as required.

Education and Experience:

BS/BA degree with a scientific emphasis preferred. ASQ Certified Quality Engineer preferred. Minimum of 3 years' experience in a related regulated health care business environment. Equivalent combination of education & experience will also be considered.

Qualifications:

Technical Skills

Ability to define problems, collects data, establish facts, and draw valid conclusions.
Able to formulate an approach and plan projects.
Ability to understand mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentage, ratios, metric measurement and proportions to practical situations.

Leadership

Lead, manage, and implement initiatives to support the QA/RA Department goals and objectives.
Proactively communicate negative and positive trends to the organization in support of on-going goals and metrics.

Data Analysis

Analyze and interpret data to meet tight deadlines.
Make recommendations based on review of numerical data, written reports and trends.
Strong problem solving skills; able to come up with alternative solutions for management consideration based on data analysis.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.

Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:

COYOTE TECHNICAL & EXECUTIVE SOURCING

Phil Montoya

Director of Sourcing

220 Miracle Mile, Suite B219

Coral Gables, FL 33134

Phone: 832-266-1610

Fax: 305-520-0138

phil@coyotesourcing.com

www.coyotesourcing.com

Like us on Facebook www.facebook.com/CoyoteTech

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For more job openings, please visit http://www.coyotesourcing.com...

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