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R&D Quality Manager


Our client is currently seeking an R&A Quality Manager.
Salary/Hourly Rate: 90K-120K
Position Overview: This position is responsible for the overall quality practices and direction of the R&D team to produce excellence in execution and risk mitigation. The incumbent will be responsible for creating processes and linkage to other cross functional teams that allows the smooth progression of projects through the company's stage gate procedure.


Responsibilities:



  • Provides quality system methodology guidance, support and review for FDA, EPA and non-regulated products throughout the design, development and change control processes

  • Actively participates on cross-functional design teams assessing design documentation for quality characteristics, including: product requirements, safety risk management, design verification, design validation, manufacturability, biocompatibility, sterilization and packaging

  • Serves as a technical resource for problem investigations to guide root cause analysis / corrective action development

  • Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other applicable standards

  • Leads safety and compliance within R&D. Interfacing directly with corporate QA and EH&S.

  • Leads continuous improvement efforts toward data integrity and research processes. Implements a regular cadence of compliance audits within R&D laboratories.

  • Reviews design history files for traceability, cohesion and risks.

  • Takes an active role in providing solutions to remediate previously identified gaps

  • Owner of R&D lead CAPAs

  • Analysis, trending and presentation of quality metrics


Qualifications:


Required Knowledge:

  • Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry - Quality Risk Management

  • Experience interacting with regulatory agencies and notified bodies

  • Good knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality performance.

  • Knowledge of medical device biocompatibility and engineering change management an advantage


Required Experience:

  • 7+ years of working experience in either pharmaceutical, medical device or FMCG industries


Education Requirements:

  • University Degree in a Scientific Discipline required

  • Master's an advantage

  • Kaizen/Six Sigma Green Belt an advantage


Qualifications:
Required Knowledge:
Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry - Quality Risk Management
Experience interacting with regulatory agencies and notified bodies
Good knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality performance.
Knowledge of medical device biocompatibility and engineering change management an advantage
Required Experience:
7+ years of working experience in either pharmaceutical, medical device or FMCG industries
Education Requirements:
University Degree in a Scientific Discipline required
Master's an advantage
Kaizen/Six Sigma Green Belt an advantage

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