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Quality Engineer in Franklin, WI at Parallel Employment Group

Date Posted: 12/12/2018

Job Snapshot

Job Description

Quality Engineer - Medical Manufacturing Industry in Franklin, WI

Join the Keystone Group as a direct hire Quality Engineer supporting this exciting medical / pharmaceutical global client organization BD Medical as they impact the health and lives of patients. Your 3-5 years experience in medical device / pharmaceutical manufacturing, as well as your knowledge and experience in ISO 13485 quality system requirements will help us in 'Advancing the World of Health'. Your active role will be in the quality and manufacturing processes required to ensure products meet quality standards, while meeting all design control and other regulatory requirements.

PRIMARY DUTIES - Quality Engineer / Technician

The essential functions of this position include but are not limited to:

Lead and support projects, as directed by management. Document corrective and preventive actions within the BD Franklin, WI Quality Systems. You will establish and implement programs designed to assure control of processes and products that meet or exceed established standards and specifications. Document changes with the manufacturing plants change control system. Statistically analyze environmental monitoring data. Process lot releases accurately and in a timely manner to prevent customer backorders. Maintain, coordinate and document all functions of the calibration system. Process NCR’s (Non Conformance Reports) accurately and quickly. Informs management of quality problems and solutions relative to FDA and ISO compliance. Reviews Device History Records and releases product for distribution. Need to be able to multi-task as priorities may change during the course of the day. Revise procedures as required.

RESPONSIBILITIES: •Implement and support projects to meet quality and operational goals

•Responsible for coordination and support of systems to assure product and process compliance

•Act as a plant CAPA Leader

•Manage calibration program

•Document Non-conformances and deviations

•Analyzing (root cause analysis) and resolving (action plan) issues affecting quality.

•Write and revise policies and procedures relating to product quality and process control.

•Coordinate environmental monitoring systems and trend data

•Coordinate media fills

•Provides guidance and acts as a backup for training

•Support and back-up all lab and facility wide testing activities

•Coordinate outside lab organism ID testing

•Assist in the documentation of validation protocols/reports and execution of validations

•Assist in external audits and supplier certification processes, as needed.

•Review and approve all QC Tech paperwork (incoming inspections, sample test requests, etc…)

•Support clean room operations and enter clean room on routine basis

Bachelor’s degree - 4 years Engineering, Business, or Manufacturing related, with a technical background and 3-5 years experience in Medical Device or Pharmaceutical clean room manufacturing environment highly preferred.

•Prefer knowledge or experience with ISO 13485, 21-CFR 820, FDA quality system requirements

•Strong technical, problem solving, and organizational abilities, strong leadership, interpersonal relation, and communication skills, attention to detail and accuracy a must, strong mathematical, analytical, and statistical skills, able to prioritize tasks, work independently, take initiative to accomplish assigned tasks, and offer proven experience in coordinating operational activities in a regulated industrial setting.

•Ability to use various computer software programs including strong knowledge of windows based programs including Microsoft Excel and MiniTab.

•Working knowledge of validations (IQ, OQ, PQ), DOE’s, and process FMEA.

• Flexibility of working hours due to audits, visitors, etc.

Equal Opportunity Employer

Benefits:

Competitive wage at: $80,000+/year depending upon prior experience

Health, Vision, Dental, Paid Vacation / Holidays

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Order: 489068