Senior Quality Engineer I

Senior Quality Engineer I

Requirements

• Working knowledge of domestic and international quality/regulatory standards related to our products
• Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.
• Working knowledge of Werfen products, technology and manufacturing processes including impact on customers and patient requirements.
• Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives.
• Bachelor’s degree or equivalent in engineering or science
• A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 5 years of experience with an advanced degree

Responsibilities

• Participates in the generation and review of quality documents throughout the product lifecycle.
• Advises and directs teams regarding compliance to procedures, standards and regulations. Implements changes to procedures in alignment with evolving regulations.
• Ensures product quality meets requirements and documentation is complete prior to approval.
• Participates on core teams supporting new product development or design changes.
• Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS.
• On projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of Werfen products.
• On new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available.
• Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
• Ensures application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution and marketing of Werfen products.
• Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements.
• Works with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective/preventive actions (CAPA).
• Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
• May manage and supervise the work of others.
• Leads cross-functional projects on technical and quality issues.
• Identifies compliance gaps and takes appropriate corrective actions as needed.
• Defends documents and procedures in internal and external audits.
• Participates in and may lead quality system improvement projects as required.

Preferred Qualifications

• ASQ Quality Engineering Certification – Desirable
• LEAN/Six Sigma Certification – Desirable