Manager, Quality Control

Integra Lifesciences Holdings Corporation Boston , MA 02298

Posted 4 weeks ago

Overview

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.

  • Manages the team to build and maintain an effective workforce for Quality Control activities.

  • Prioritizes the completion of quality inspection, test and monitoring tasks to meet procedural requirements and production schedules.

  • Ensures ongoing compliance to documented processes and Good Laboratory Practices (i.e., GLPs and ISO17025).

  • Develops, maintains, and improves On-The-Job Training program for QC personnel including cross-training.

  • Reviews and approves all Laboratory and Inspection/Test SOPs.

  • Works closely with Quality Engineers to ensure compliance to Equipment Management Program and Process/Test Method Validation requirements.

  • Works closely with Production leaders to ensure effective workflow execution during manufacturing.

  • Assists with Control of Nonconforming Product process activities (e.g., initiation of NCs, product quarantines/holds).

  • Actively participates in cross-functional Site Quality Leadership Team as primary QC representative.

  • Serves as primary SME for QC during internal and external audits.

  • Generates QC metrics as required by procedures and as requested by Director, QA Operations.

  • Leads or support quality initiatives/projects as assigned by Director, QA Operations.

Qualifications

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Education and Experience:

  • Bachelor's degree in Quality or Life Sciences

  • 5-7 years of working experience in Quality Assurance/Control.

  • Minimum of 5 years experience in a regulated industry, preferably Medical Device Industry.

  • Minimum of 5 years experience supervising laboratory.

  • Minimum of 3 years personnel management and mentoring.

  • Expert knowledge and application of GLPs.

  • Working knowledge of medical device regulations (including FDA QSRs, ISO13485).

  • High level of technical aptitude

  • Excellent mathematical skills (sampling plans).

  • Ability to use a wide assortment of QC inspection, measuring and test equipment as well as laboratory techniques to ensure product is manufactured and functioning according to specification.

  • Ability to read and interpret technical documentation and references.

  • Ability to comprehend and execute procedures.

  • Experience with CAPA processes (e.g., nonconforming product, product holds investigational techniques,).

  • Demonstrated experience in successfully leading a team.

  • Experience in project management.

  • Ability to effectively communicate to all levels of management within the organization.

  • Demonstrated ability to work cross-functionally in a team environment.

  • Ability to communicate effectively (both written and oral)

  • Exceptional conflict-resolution skills.

  • Familiar with the MS Office Suite, including Microsoft Visio.

  • Familiar with ERP systems, Oracle preferred.

  • Quality certification preferred

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Manager, Quality Control

Integra Lifesciences Holdings Corporation