Director, Quality Engineering

3 weeks ago

Milpitas CA, United States Endologix Full time

Overview

The Director, Quality Engineering is responsible for Quality teams, QA & QC, involved in producing and supporting our products. This role has responsibility for all quality operation activities related to manufacturing of Endologix products globally and for working with peer functions in Operations, Supply Chain, R&D, and Regulatory to identify quality engineering, assurance, and control strategies to ensure the highest quality standards for our products. In addition, this role is a key leader in the problem-solving process for issues affecting product and service quality.

Responsibilities
  • Lead Quality Operations across the business.
  • Mentor resources to ensure they receive training to execute their roles.
  • Assure that activities are following compliance in the respective areas that are applicable from FDA GMP/GLP, ISO 13485/8, CMDR, CMDCAS, Medical Device Directive, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other national and international standards as necessary.
  • Provide quality engineering support. Address product related issues arising in manufacturing and assure elements such as NCR, CAPA, audits and scrap are being used properly.
  • Perform investigations to determine root cause. Assign and ensure completion of corrective and preventive actions.
  • Completes investigations in a timely manner to ensure customer service levels are maintained.
  • Coordinates the reporting and provides trend analysis for non-conformance incidences.
  • Partner with Manufacturing/Operations, R&D, supply chain and other functions to ensure quality assurance and engineering methods drive the highest quality products and processes from development through manufacturing in accordance with applicable requirements.
  • Lead implementation and infusion of quality engineering tools throughout the organization to drive methodical and process-based approaches to product and process development. Utilize same approach to existing products and processes, applying where possible, new technologies and methods.
  • Utilize quality toolbox including six sigma methodology, lean principles, advanced statistics, reliability engineering, design assurance techniques, and other proven tools.
  • Support sustaining and new product projects.
  • Support the manufacturing in their efforts to ensure production needs are met.
  • Determine equipment qualification, process validation, and product line design/modifications requirements. Advise Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products. Support design transfer activities.
  • Work with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures. Work with Facilities to establish and maintain effective environmental monitoring systems.
  • Lead development of Risk Management documentation.
  • Assist in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
  • Promote and organize training activities related to product quality, cost, reliability, and regulatory compliance. Develop strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
  • Maintain an up-to-date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
  • Develop systems for the identification, analysis, correction, and prevention of quality issues.
  • Work with Quality and the Operations Team to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration, and celebration of good work, involvement and development of all people within the team.
  • Instill a sense of urgency to ensure goals are met in a timely manner while meeting regulatory and quality standards and customer requirements.
  • Be self-directed with the ability to take initiative and be accountable for results, and demonstrate confidence, maturity and integrity.
  • Communicate effectively to all levels of an organization.
  • Ability to prioritize work activities to ensure critical priorities; those with highest impact on goals.
  • Protect Endologix confidential and proprietary information in accordance with Legal guidelines.
  • Perform other duties as assigned.
Qualifications

A Bachelor’s degree in a technical discipline is required.

Master’s Degree preferable

Minimum of eight to ten (8-10) years of Quality Engineering experience in the Medical Device.

Strong communication and people management capabilities. Ability to lead change through education, sales, and negotiation skills.

Proven managerial and leadership skills leading to consistent improvement in team performance, process capability and product quality. Preferred experience managing multiple sites.

ASQ Certification in any of the Quality Disciplines strongly desired.

Lean or Six Sigma training strongly desired.

Training on regulated industry quality management.

Demonstrated experience and success in the application of Quality Management principles

Demonstrated experience and application of US and International Medical Device regulatory schemas and standards, such 21 CFR 7, 803, 806, and 820, EU Medical Device Regulation, Medical Device Single Audit Program (MDSAP)

Excellent analytical and decision-making skills.

Experience in a fast-paced remedial environment leading to rapid growth.

Demonstrated experience in communicating successfully with regulatory agencies such as: FDA, PMDA, MHLW, EU

Ability to travel between Milpitas and Santa Rosa on regular basis, with occasional travel to Irvine location.

Compensation: $190,000 to $215,000 annual salary, plus Bonus and Equity potential

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