Quality Engineer

7/21/21

King of Prussia, PA 19406

1307

FullTimeRegular

Quality Engineer

The Quality Engineer is primarily responsible for leading quality control (QC) and quality assurance (QA) activities. Key responsibilities within the QC function include verifying the accuracy and dependability of test results supporting product and process development, and recommending test assays for in-process, release, and shelf-life testing.

Key responsibilities within the QA function include managing identification and traceability processes, receiving, inspection, and release of commercial product, supporting equipment control, and directing or participating in the completion of quality events (change controls, non-conformances, investigations, and corrective/preventive actions).

Essential Duties & Responsibilities:

  • Lead the stability program at for all new and modified devices, including ongoing monitoring studies of commercial devices
  • Lead quality control activities including receipt and inspection of commercial and non-commercials goods and materials
  • Manage the part number assignment procedure and log
  • Assist Product Development (PD) and/or Operations on specification development ensuring that labeling and certification requirements are documented, storage conditions are appropriate and available internally, and expiry periods are scientifically valid
  • Participate on product development teams offering input on product design (user needs, inputs/outputs), risk analysis, verification and validation testing including design, testing, and sample size requirements
  • Assist with the development and approval of quality agreements with development and manufacturing partners
  • Manage test method validations, including transfer and validation of methods to/from development and manufacturing partners
  • Support the RA/QA department in quality system development and improvement, including but not limited to, review and revision of quality policies and procedures
  • Direct or participate in the completion of quality events (change controls, non-conformances, investigations, and corrective/preventive actions)
  • Manage the complaint handling process including reporting to regulatory authorities, as required
  • Lead internal audits and/or supplier’s (second party) quality systems
  • Participate in regulatory inspections

Requirements:

  • Bachelor’s degree in scientific (biology, chemistry, biochemistry, physics, etc.) or engineering discipline
  • Certifications, such as CQE, are a plus
  • 3-5 years in a regulated industry, medical device experience preferred
  • Knowledge of US regulations and standards
  • Lead auditor experience and/or experience interacting with regulatory agencies, a plus
  • Ability to multi-task, work in a fluid environment, manage time efficiently, achieve goals with minimal supervision, and effectively interact with other employees, departments, service providers, and development/manufacturing partners
  • Ability to develop, implement, maintain, and improve processes and procedures which support the quality system
  • Ability to analyze data and justify the statistical technique and sample sizes used
  • Working knowledge of analytical lab equipment such as tensile testing machines, differential scanning calorimeters, visocometers, and spectrophotometers, a plus
  • Knowledgeable on all Microsoft Office Applications (Word, Excel, PowerPoint, Visio), Adobe Pro, and Minitab; familiarity with an electronic document management system (MasterControl) and/or enterprise resource planning software (Sage), a plus

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