Quality Engineer II

Lancesoft West Chester , PA 19380

Posted 3 months ago

Responsibilities:

Primary responsibilities include activities associated with conducting complaint investigations including: triage of incoming complaints, documenting requirements for evaluations and investigations, conduct of investigations and communications of performance and safety issues.

Initiate and lead projects involving failure investigations, root cause analysis using appropriate investigative techniques and statistical methods.

Summarizing the results of data analysis and investigations into clean, concise complaint documentation and presentations and reports for peers, cross-functional teams and management. Support business partner processes in post market surveillance, customer quality regulatory reporting, operations/operations quality and new product development.

Operates in a safe, effective, and professional manner compliant to all policies, procedures, and regulations including health and safety.

Position Duties & Responsibilities:

Triage incoming complaints

Document requirements for investigations

Investigate customer complaints for product quality issues

Lead projects involving failure investigations. Root cause analysis

Utilize statistical tools to analyze complaints and corrective actions

Participate in HHEs as required

Work with manufacturing, R&D, Medical Affairs, and international affiliates as required.

Summarize results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management

Summarize data to support post market surveillance, regulatory responses, etc.

Interface with key business partners including R&D, Operations, Post Market Risk Management and Surveillance, Quality, Regulatory and Compliance, to insure complete and thorough investigations.

Conduct user interviews and manufacturing and R&D visits to ensure rapid response to field safety issues.

As needed, be key interface to ensure events are escalated in a timely manner and per procedure.

Gather data working and preparing response for the US and international regulatory agencies

Provide daily support to the Complaint Teams and ensure complaint investigations are robust and well documented.

Assist in training and mentoring of new employees, provide guidance and direction to peers, and serve as an expert in the investigation process.

Participate on CAPA teams and acting as CAPA Action and Internal Audit task owner

Other duties as assigned.


Professional Experience

Requirements:

A minimum of 4 years experience in a GMP and/or ISO regulated environment.

Medical device industry preferred

Previous root cause analysis skills is required.

Experience conducting and reviewing complaint investigations highly preferred.

Project management experience preferred

Ability to collaborate with business partners at all levels is required.

Knowledge of process and design excellence tools preferred.

Proficiency with Microsoft Office Suite required.

Knowledge of CAD software highly preferred.

Excellent communication and presentation skills required.

This position may require up to 10% travel, including light international travel. This role will be based in West Chester, PA and does not offer relocation benefits.

Educational Requirements:
A minimum of Bachelors Degree in Engineering is required.


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Quality Engineer II

Lancesoft