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Medical Quality Engineer (2 Positions)

Job description (Tasks/Responsibilities):

  • Assist Engineering in the development of trial and validation protocols and generation of final reports
  • Provide assistance and guidance to Engineering and Manufacturing personnel during process development activities.
  • Work with Engineering and Project Management teams during process development and change activities utilizing appropriate Quality tools to assure robust and fully documented changes and processes
  • Evaluates existing processes and leads process improvement activities by assuring that all processes are completely defined and adequately documented and controlled using appropriate Quality tools, (FMEA, DOE, SPC, Method Development, GRR, etc).
  • Determination of Process Capabilities
  • Develop problem solving tools and train appropriate personnel
  • Assist or Lead the Supplier Improvement process using inputs from the SCAR, NCM and Supplier Audit process
  • Assists in external audits by regulatory agencies, certifying bodies or customers
  • Lead problem solving teams or be a resource for problem resolution. This includes leading or assisting in Root Cause analysis and Corrective Action identification and implementation. Able to lead and participate in concurrent teams.
  • Conduct, or assist in, customer and supplier visits as required conferring on specific quality issues and/or concerns
  • Develops and initiates standards and methods for inspection, testing, and evaluation.
  • Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of the assigned product or component.
  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
  • Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
  • Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
  • Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
  • Reviews all purchased products or components and provides input to the decision to accept the product and future purchases from the vendor.
  • Documents data obtained during all quality activities consistent with company policies and procedures.
  • Develops new approaches to solve problems identified during quality activities.
  • Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.
  • Prepares reports to communicate involvement and results of quality activities.
  • Prepares and presents technical and program information to team members and management.
  • Maintains environmental, water sampling, and / or air sampling.
  • Maintains a working knowledge of government and industry quality codes and standards.
  • Interfaces with Regulatory Agencies and Certifying Bodies and provide guidance to company management to ensure compliance
  • Interpret Regulatory requirements as they pertain to company and ensure that processes and systems are developed and maintained for compliance.
  • Responsible for maintaining internal audit process and ensures all observations an non-conformancies are addressed within prescribed timeframe to meet requirements
  • Conducts Supplier Quality Audits and manages corrective actions to closure.
  • Maintains the company GMP program including training, corrective controls and refresher training
  • Adhere to all Company policies, rules, procedures and housekeeping standards as well as the Food and Drug Administrations Good Manufacturing Practice, (cGMP), for Medical Devices and In Vitro Diagnostic Products, 21 CFR Parts 820, Quality Systems Regulation.
  • Provides feedback and pro-active communication to supervisor, management, and co-workers to ensure efficient and effective operations. Contributes input to management based on knowledge of processes toward process and product improvement efforts of the company

Supervisory Responsibilities:

May directly or indirectly supervises 1 to 4 employees in Quality Assurance. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Skill Requirements:

Certificates, Licenses, Registrations:

Six Sigma Green Belt, ASQ Quality Engineer preferred, Valid Driver's License

Other Skills and Abilities:

Experience in ISO certified industry, ISO -13485 Lead auditor training and Experience with performing audits, working knowledge of 21CFR820, QSR all desirable

Education Requirements:

Bachelor's degree (B. A. or B.S.) from four-year college or university – preferably engineering or technical; plus 5 years related experience and/or training in a regulated industry preferably medical or pharmaceutical, or equivalent combination of education and experience.

Location (City/State):

Denver, PA

Company Description:

Precision Medical Full Service Contract Manufacturer

To Apply:

For consideration or to discuss this opportunity send your resume and salary requirements to Jess Stinson at jess@centuryassociates.com. Please include “Medical Quality Engineer Positions” in the subject line.