Quality Manager Jobs

About The Position

Requirements

• Bachelor's degree in mechanical engineering, chemical engineering, biomedical engineering, or other engineering related degree.
• Minimum of 5-7 years medical device experience or similarly regulated ISO or cGMP/GLP environment.
• Previous experience with catheters and/or medical devices.
• Experience in conducting complaint/CAPA investigations.
• Proven record of validation and compliance of regulated products.
• Experience with regulatory requirements and guidance for component and product testing including ASTM, ISO and ICH.
• Strong statistical background and practical application of statistical techniques (Six Sigma, DOE, etc).
• Demonstrated problem solving and root cause analysis skills using risk-based approach.
• Strong attention to detail and accuracy.
• Ability to train others, work independently or in a team setting.
• Effective presentation/communication skills, prioritization and resource management skills.

Nice To Haves

• Interventional cardiology products experience.
• E-beam sterilization validation and software validation experience.
• ASQ certification (QE, and/or Auditor).

Responsibilities

• Provides direct management and technical support to Quality Engineers.
• Supports REVA Medical business needs, including compliance, risk remediation, new product development, and cost reduction efforts.
• Provides support, mentoring, and coaching to QEs for technical principles, quality tools, and systems.
• Develops personnel, including succession planning and contingency management.
• Provides quality engineering leadership, oversight, and direction in problem-solving and team-building.
• Supports new product development and product maintenance using quality engineering skills for medical devices.
• Ensures REVA products are designed using systems that comply with applicable quality standards, industry/government regulations, and customer expectations.
• Develops and ensures execution of process/equipment IQ/OQ/PQ protocols and reports.
• Conducts test method qualifications and validations.
• Develops gauge reliability and repeatability studies.
• Develops equipment calibration procedures.
• Develops sampling plans for incoming materials, in-process, and finished product testing.
• Responsible for product-related investigations and corrective actions.
• Maintains relationships with suppliers to resolve critical issues and investigations.
• Leads execution of Quality activities to meet Business Goals and quality metric targets.
• Develops technical solutions and program management for complex problems.
• Ensures customer requirements are met as a product expert.
• Leads continuous improvement and strategy development to improve Quality.
• Reviews and approves assigned controlled documents.
• Establishes and maintains a team structure for excellent customer service and optimal resource utilization.
• Provides required input for Management Review.
• Promotes the use of statistical tools in product design and development.
• Leads Risk Management activities for products under design authority.
• Provides feedback for budget preparation and adheres to approved departmental budget.
• Participates in and may lead multi-disciplinary projects.
• Participates in customer product complaint analyses, evaluation, and investigation.
• Participates in updating, maintaining, and approving risk analysis/risk management documentation.
• Participates in internal/supplier audits and interacts with external regulatory inspectors.
• Manages special projects and other assigned duties.