Senior Engineer II, Quality

Overview

Position Summary

The Quality Senior Engineer II applies advanced insight, experience, knowledge, and skill, as well as implements and determines best practices and procedures, to support complex quality-related engineering activities (including, but not limited to, product development, verification and validation) and to solve multifaceted quality issues that relate to the implementation, maintenance and support of new and existing products

Responsibilities

Key Accountabilities:

• Lead quality planning activities; ensure design control and risk management compliance according to regulations.
• Write, review, and approve validations ensuring systems, utilities and processes comply with regulations and standards.
• May lead validation project teams; maintain and communicate appropriate schedules, budgets, etc.
• Support risk assessment teams and problem-solving activities related to product or process quality issues; lead investigations of non-conformances, identify root cause, and determine/implement appropriate corrective action plans.
• Develop and implement statistical methods and sampling plans.
• Support design control project teams: ensure predetermined requirements are met and that compliance is maintained.
• May lead continuous improvement activities to enhance the quality system, processes, products.
• Lead activities that ensure products and processes comply with the requirements of the quality management system and external regulating agencies.
• Support the maintenance of the quality management system.
• 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 microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances.
• Works with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
• Provide training to build quality awareness.
• Maintain up-to-date knowledge of Quality Systems Regulations (QSR) and applicable ISO standards.
• Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies. Supports internal and external audits.
• Ensure all assigned projects/processes are in compliance with relevant regulations and other applicable requirements.

Networking/Key relationships:

• Manufacturing/Operations
• Manufacturing Engineering
• Regulatory Affairs
• Research & Development
• Service

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor of Science degree, or equivalent experience
• Minimum of ten (10) years of experience, or seven (7) years with an advance degree, preferably within a regulated medical device or pharmaceutical environment.
• ASQ certification and/or Six Sigma Green/Black belt strongly preferred.

Skills & Capabilities:

• Advanced understanding of 21 CFR Part 820, ISO 14971 and ISO 13485 is required.
• Advanced understanding of quality engineering principles including risk management, root cause investigation, process validation, process capability, trend analysis, statistical methods, and acceptance sampling.
• Advanced Understanding of current Good Manufacturing Practices (cGMP) & Good Documentation Practices (GDP).
• Advanced Understanding of Design Controls.
• Advanced Understanding of metrology principles.
• Experience with large enterprise resource planning (ERP) system required.
• Experience leading cross functional projects to a timely and effective conclusion
• Experience with RoHS and REACH preferred.
• Experience working with terminal sterilization requirements, gamma sterilization processes preferred.
• Understanding of Sterilization principles.
• Understanding of Supplier Management.
• Advanced understanding of calibration principles.
• Strong understanding of stability testing.
• Knowledge of Microsoft Office required; knowledge of statistical software preferred.

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required.
• Accuracy: Work is accurate and complete.
• Performance Standards: Demonstrated ability to meet department goals.
• Communication: Excellent written, verbal and presentation skills.
• Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality.
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs.
• Collaboration: Ability to work within a multi-function team to bring best solutions to the team or customer.
• Independence: self-motivated-works under minimal supervision.
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties.
• Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers.
• Problem Solving: Promptly and effectively handles issues and problems.
• Decision making: Makes decisions based on data and risk determination.

Travel requirements:

Approximately 10% of the time.