Quality Engineer III

Werfen•San Diego, CA

5d•$100,000 - $125,000

About The Position

The Quality Engineer III creates quality system documents, including procedures and work instructions, and supports a broad range of quality-related engineering activities. These include process and product development, risk management, root-cause investigation, risk assessment, and verification and validation. The role supports or leads continuous improvement projects and serves as a resource for applying statistics, including capability studies, gage R&R, test method validation, and acceptance sampling plans. The position works across functions to address product and process quality issues, support design controls and process validation, evaluate product non-conformances, and recommend or implement corrective and preventive actions. It also contributes to audits, reviews change orders, and interprets regulations and procedures to ensure documentation is defensible to auditors and regulatory bodies. The role may prepare technical microbiology and sterility assurance reports and recommendations. The annual base salary range is $100,000 to $125,000, and the position is eligible for a bonus. Compensation depends on factors including education, relevant experience, skills, knowledge, and business needs. Werfen describes itself as a family-owned diagnostics company founded in 1966, operating directly in 30 countries and through distributors in more than 100 territories, with more than 7,000 employees worldwide.

Requirements

Bachelor’s degree or equivalent, plus 3 to 5 years of previous experience, preferably in a regulated medical device or pharmaceutical environment.
Knowledge of risk management and ability to apply quality principles, including GMPs and EN ISO 14971:2012, to the R&D environment.
Broad knowledge of quality engineering principles.
Broad knowledge of Quality System Regulations.
Experience with statistical sampling and analysis, design of experiments (DOE), and validation.
Good technical writing skills.
Good communication and presentation skills.
Knowledge of Microsoft Office, statistical software, and large enterprise resource planning (ERP) systems.
Demonstrated problem-solving skills.
Strong planning and organizational skills.
Ability to collaborate internally and externally and work with vendors, subcontractors, and consultants without supervision.
Understanding of and ability to demonstrate aseptic technique.
Experience with GLP principles.

Nice To Haves

ASQ certification and/or Six Sigma Green Belt or Black Belt.
Expertise in Gamma Sterilization.

Responsibilities

Write, review, and approve quality system documents that comply with applicable regulations and standards.
Participate in or lead process validation teams.
Work cross-functionally to solve product or process quality problems; investigate non-conformances, identify root causes, and determine and implement appropriate corrective action plans.
Support design control project teams, ensuring predetermined requirements are met and compliance is maintained.
Participate in internal and external audits.
Conduct risk and trend evaluations for product non-conformances.
May prepare technical microbiology and sterility assurance reports and formulate recommendations related to product non-conformances.
Work with manufacturing, R&D, Service, Distribution, Sales & Marketing, and external parties as needed to recommend or prepare corrective and preventive actions (CAPA).
Review and approve change orders related to product performance, process changes, labeling, and marketing communications as required.
Interpret regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies, and support internal and external audits.
Prioritize urgent matters.
Lead cross-functional projects to timely and effective conclusion.