Sr Engineer (Quality)

Fresenius Kabi USA•Warrendale, PA

About The Position

Sr. Engineer who will analyze, implement, and execute processes to ensure product quality. Requires working in a cross-functional team environment including but not limited to members from Manufacturing, Clinical, Regulatory, and Marketing. No direct reports. Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires. We ask that candidates answer all work authorization questions fully and accurately during the application process.

Requirements

B.S. degree in Engineering. (Mechanical, Electrical, Biomedical, or Materials preferred)
3+ years’ experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry.
Quality engineering or Product Development experience preferred.
Knowledge of lean manufacturing, Six Sigma principles and Project Management a plus.
Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods.
Knowledge of quality control process and statistical techniques.
Understanding of manufacturing processes and techniques.
Analytical and problem solving skills.
Strong attention to detail.
Proficient with Excel (PivotTables, trending, charting) and other statistical software
Excellent verbal and written communication skills.
Interpersonal skills and the ability to work with cross-functional teams.

Nice To Haves

CQE certification a plus

Responsibilities

Utilizes project management skills to ensure timely completion of projects/programs, in support of corporate, plant, and/or departmental goals
Supports and/or participates in in-depth internal and external audits
Assists with the preparation for Management Review meetings.
Monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
Gather and analyze data for root cause analysis. Drive efforts to assure CAPAs are opened and completed appropriately. Work with Engineering and Manufacturing to develop and implement corrective actions.
Support complaint sample evaluations and investigations. Track complaint data to identify actionable trends. Perform risk assessments and analysis
Serves as quality representative for New Product Development. Contribute to requirements definitions and ensure that reliability, quality, and safety requirements are met. Work closely with Engineering to develop test protocols and reports.
Actively contribute to Change Review Board as part of change control process.
Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.