Quality and Compliance Manager

ZEISS Group•Exeter, CA

2d•Hybrid

About The Position

The Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards. This position works very closely with the Manufacturing Engineering team, is directly involved in day-to-day production processes, and can act as a backup for all quality-related responsibilities.

Requirements

Solid understanding of quality system requirements set by the major regulatory frameworks for medical devices and combination products.
Relevant experience in managing and overseeing quality aspects in distribution, preferably in disposable devices as well as pharmaceutical products.
Ability to effectively translate quality requirements into practical directions for the organization.
Experience in management of FDA and/or Notified Body inspections
High level of integrity and ethical standards.
Ability to multi-task and methodically manage projects based on business priorities and resource availability.
Ability to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment.
Collaborates effectively across a diverse network.
Open-minded for improvement opportunities and change towards striving for best-in-class compliance performance.
Ability to think creatively, proactively identifying alternative solutions to problems.
Experience in people management.
Effective communication/interpersonal skills.
Fluent in English (written and spoken)
Advanced level in Microsoft Office suite applications.
Minimum Bachelor degree in a relevant field of engineering.
Qualification in Quality Assurance (e.g. six-sigma, lean, ASQ).
Minimum 5 years in a senior role in Quality Assurance in medical device or pharma industry

Responsibilities

Identify and assist with process validation activities.
Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
Inspect product including labeling and documentation for release of finished goods.
Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs
Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
Oversee creation and review of documentation for nonconforming products.
Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed
Keep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.
Assist with revisions and updates to quality procedures, standardized work instructions
Participate in supplier management activities.
Identify supplier quality issues and report to management in timely manner.
Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).
Other duties as assigned.