Lead Engineer, Quality Assurance

Posting Date 2 months ago(3/31/2022 12:49 PM)
Requisition ID
2022-10553
Job Location(s)
Vandergrift PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Vandergrift
Category
Quality

Overview

The Senior Engineer is a leader in the department tasked with solving Quality Engineering problems, while leading the Quality Assurance in company projects. Responsible for supporting the corporate Quality Policy in accordance with customer, international and company requirements.

Responsibilities

• Responsible for supporting the implementation and maintenance of the company quality system.
• Knowledge of applicable standards for manufacturing medical devices.
• Development of validation protocols, administration attesting and completion of final test reports.
• Assist Engineering Department in development of testing requirements during design / development phases.
• Contribute technical/scientific expertise and direct to department engineers and other company business functions
• Act as a mentor to other personnel in the QA Department
• Knowledge of applicable quality and medical device standards.
• Knowledge of US FDA, QSR, EU MDD and Canadian MDR.
• Monitor status of relevant regulations, standards and directives.
• Evaluate and develop improved techniques for the control of quality, reliability and safety of products.
• Support the system of documents which make up the Quality System.
• Report on performance/review as a basis for improvement of the Quality System.

• Lead corrective and preventative actions and assure implementing verification
• Administration of Risk Assessment activities associated with Quality Assurance.
• Coordinate Internal Audit Program.
• Identify, evaluate, record and initiate correction or prevention of quality related problems.
• Promote knowledge of QPM and QSP's.
• Communicate with other departments to exchange information, as required.
• Provide input to QA Manager as to quality assurance actions and status.
• Provide input to QA Manager to improve department operation and efficiency.
• Interface with other Cook Companies concerning corporate regulatory or quality assurance.
• Works with external sources and communicates information to manager.
• Positive representation of the company to the outside worid.
• Responsible for compliance to company's Quality Policy Manual/ safety policies.
• Confidential access of the company's new and/or existing product designs, plans and customer base.
• Provide technical/ strategic input on managing company intellectual property.

Qualifications

• College degree, BS or equivalent Quality Engineering experience.
• Knowledge of quality tools and principles, basic knowledge of statistics.
• Knowledge of auditing skills (CQA preferred).
• Required to sign an Executive and Sales Employee Agreement for Protection of Employee Business.
• Must pass a post-offer physical exam and drug test

• Ability to read, write and understand product documentation.
• Self-starter with good interpersonal, organizational, and problem solving skills.
• Detail oriented with above average verbal and writing skills.
• Demonstrated ability to work effectively and collegially with employees

 

Physical Requirements:

• Ability to occasionally lift a minimum of 30 pounds
• Ability to conduct and hear ordinary conversation and telephone communication

• Limited exposure to hazardous chemicals used in testing or manufacturing of products 
• Majority of day spent in clean, climate controlled office area

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