55 applicants

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Company

Original Job Post

Confidential · 2 days ago

Senior Quality Engineer

Boston, MA

Contract

Onsite

Senior Level

4+ years exp

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Business DevelopmentConsulting

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Hiring Manager

Manoj Koneru

Insider Connection @Confidential

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Responsibilities

Must have Process Validation experience.

Provide technical understanding of manufacturing equipment and processes.

Utilize statistical software packages for data analysis and decision-making.

Ensure compliance with GMP/ISO regulations and validation regulations.

Perform troubleshooting and problem-solving activities.

Manage product/process Risk Management according to FDA and ISO standards.

Communicate effectively and collaborate in a team-based manufacturing environment.

Qualification

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Process validationManufacturing equipmentStatistical softwareFDA regulationsEuropean regulatory environmentGMP/ISO regulationsValidation regulationsRisk managementMicrosoft OfficeProblem solvingCommunicationInterpersonal skillsTeamworkCollaboration

Required

A minimum of 4-6 years of related experience.

Must have Process Validation experience.

Good technical understanding of manufacturing equipment and processes.

Knowledge of statistical software packages (e.g. Minitab) with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making.

Experience working in both an FDA and European regulatory environment in manufacturing/operations.

A thorough understanding of GMP/ISO regulations and validation regulations

The ability to perform 'hands on' troubleshooting and problem solving.

Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).

In-depth knowledge of product/process Risk Management (FDA and ISO standards).

Strong communication and interpersonal skills.

Must have the ability to function in a team-based manufacturing environment.

The ability to collaborate with all levels of management in a cross-functional team environment.