BEPC has an open position for Quality Engineer in Plano, TX!
Contract W2 Period: 6-month contract with possibilities for extensions
Pay & Benefits: $40.00 - $45.71/hr. +Medical, Dental, Vision and Life Insurance

Description:

· participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects, accountable for generation of PDP design verification test plans/reports for product/system requirements,

· Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments,

· Lead identification of essential outputs and generate Essential Output reports, accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customer/system/product requirements, work with design engineering in the completion of product verification and validation,

· DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps, complete document change request reviews in a timely and objective manner, identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements,

· Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements, assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues, support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives

· Develop incoming inspection processes and document incoming inspection activities.

· Provide in-process QA support to include inspection and document review.

· Complete final acceptance activities.

· Manage the sterilization process, including validations and product sterile loads.

· Track nonconforming material and lead Material Review Board (MRB) efforts.

· Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies, and contract processing.

· Lead complaint investigations on returned product.

· Manage corrective action and quality improvement activities.

· Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.

· Assist in the performance of quality system internal auditing.

· Support quarterly management review meetings.

· Establish, monitor and evaluate quality system metrics.

Requirements

· 2-5 Years of experience

· Bachelor level degree in an Engineering Discipline or other technical field experience, such as Mechanical or Electrical Engineering

BEOCS

Job Type: Contract

Pay: $47.71 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Plano, TX 75024: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: One location

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