Quality Engineer - Totowa, New Jersey | CareerCircle
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Quality Engineer

Actalent

02/22/2022

Posting ID: JP-002662505

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Totowa, New Jersey
Full Time
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Description:

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

• Work closely with operations and the business functions to ensure quality performance of product and processes.

• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.

• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.

• Analysis and review of concession requests. Review and approval of change management activities.

• Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.

• Proficient in risk management practices and tools, having high expertise in process risk.

• Develop and provide input for risk management by identifying opportunities and weaknesses.

• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.

• Support First Article Inspections. Proficiency in statistical methods and application.

• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.

• Assist in the development, responsible for review & approval of process and equipment validation/qualification.

• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.

• Coach and mentor others in quality topics and activities.

• Performs the job while adhering to all company policies and procedures

• Performs other related duties as necessary or assigned

Skills:

quality engineering, iso 13485, non conforming, capa, corrective action plans, audit, internal audit, quality inspection, first article inspection, risk management

Additional Skills & Qualifications:

  • Medical Device
  • 5 years of Quality Engineering
  • ISO 13485
  • CAPA
  • Corrective Action Preventive Action
  • Non Conforming
  • Complaints
  • Internal Audit
  • External Audit
  • Risk management

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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