Senior Product Quality Engineer-Remote Role, East Coast Preferred
PerkinElmer
Nơi làm việc
Hartford, CT, USA
Chi tiết công việc
This is a remote role with preference to an East Coast location.
Job Summary
We are currently seeking a Senior Product Quality Engineer that will provide quality support for product Lifecyle management. Responsible for development activities of products following design transfer requirements and internal procedures. Provides general engineering services and support for product manufacturing and quality control. The PQE is provided limited direction from the Manager to maintain the complaint and investigation processes and is capable of performing all activities and takes a leadership role with projects and product support.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
• Facilitate and actively contribute to the risk management activities Management Plans, pFMEA’s, Risk Control, etc. for new and released products.
• Supports nonconformance investigation, disposition and release activity as applicable
• Creates appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
• Assists with the review of complaints
• Assists with the department metrics and works with others to ensure department goals are achieved.
• Remediation of product documentation for changes in product compliance for new or updated standards
• Identify, investigate and implement corrective and preventive actions (CAPAs)
• Participate/Lead projects related to Design Transfers
• Review technical product documentation including device master records (DMRs), drawings, bills of materials, test protocols and reports, manufacturing work instructions, engineering change orders (ECO), etc.
• Work with manufacturing engineer/process engineer to ensure process controls are in place
• Review and/or approve reports for: test method validations, design transfer, pilot production, and process validations (IQ, OQ, PQ).
• Write, review and / or approved quality plans to support product activities both internal and external.
• Assist in external & internal audits.
• Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
Basic Qualifications:
• Bachelor’s degree
• Five plus years experience in Quality Assurance
Preferred Qualifications:
• Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus
• Knowledge of ISO 9001, Risk Management and applicable standards
• 7+ years of experience as a Quality Professional in ISO 9001 industry desired
• Knowledge of regulations and documentation practices desired
• Knowledge of Risk Management and applicable standards
