Senior Quality Engineer (Risk Process Expert)

Overview

A Senior Quality Engineer (Risk Process Expert) assures new products perform the functions intended in a safe manner and establishes compliance with the quality system. Must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. This position serves as a Quality representative on new product development (for new and existing products) and provides technical support and leadership of quality deliverables. Also responsible to support R&D and Operations during all product development phases and support creation of design controls as well as process qualification/validation activities, statistically sound sampling plans and process control plans including inspection/test method development and product investigations resulting from field complaints.

Collaborates with Regulatory, Supply Chain, Quality, Manufacturing, Engineering, and Customer Support for compliance to all specifications. Develops, applies, and reviews procedures in accordance with 21 CFR 820 and ISO 13485. Collaborates with new & existing product development teams to ensure quality standards are met. Support and/or lead root cause analysis and CAPA investigation.

The role of Senior Quality Engineer (Risk Process Expert) is further responsible for managing / monitoring the process of product risk assessment and mitigation across the organization, as per ISO 14971:2019 and ISO 14971:2019+Amd11:2021. Through the product development process, he/she must schedule and run periodic risk management meetings with all necessary parties to ensure (i) hazard analyses, dFMEAs, and pFMEAs, or alternative risk management methodologies, are completed and updated by the appropriate parties and (ii) risk mitigation work by the appropriate parties proceeds to completion with appropriate documentation. He/she must work with all necessary parties to identify applicable standards, develop interpretations for such standards, and ensure applicable application of those standards through maintenance of the internal risk management SOP which will continue to evolve along with the standards. This role will work closely with project management organization (PMO) to ensure PMO is aware of all risk management work that must be resourced and tracked through completion. By way of example, at the beginning of new product development, the management / monitoring of the process of risk assessment and mitigation will involve conceptualizing the potential hazards and potential mitigations and, as product development progresses, the process will become more specific as to the actual design Must frame the discussions and lead the meetings throughout the development process to ensure hazards are identified, mitigated, and documented. Beyond product development, he/she will also monitor and direct risk management activities related to post market surveillance and reported production and supplier deficiencies. Responsible for managing / monitoring the process to ensure the appropriate parties complete that work correctly and in an efficient manner.

DUTIES & RESPONSIBILITIES

• Work with product development teams to develop measurable goals for quality
• Manage / monitor the process of risk assessment and mitigation:
• schedule and run periodic risk management meetings with all necessary parties;
• tracking completion of hazard analyses and risk mitigations by appropriate parties;
• ensuring, when applicable, that quality plans adequately document mitigation of identified product hazard
• Support system/product risk management planning
• Support the requirements development process to assure quality of requirements and linkage to risk management file
• Work with PMO to ensure PMO is aware of all risk management work that must be tracked through completion
• Work with all necessary parties to identify standards applicable to products, develop interpretations for such standards, and ensure consistent application of those standards
• Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report
• Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices
• Create Quality Plans
• Statistics; sampling plans, Statistical Process Controls, Data Analysis, process capabilities, Gauge R&R and other methodologies
• Perform DHF/DHR review for product release.
• Participate with internal quality audits
• Assist the Quality Department on an as-needed basis.
• Other duties as assigned by Quality Manager

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

Required:

• Bachelor's degree (or equivalent experience) with 12 plus years of related experience
• Experience with the creation of Procedures, Protocols, Test Reports, and Work Instructions
• Participate in Risk Analysis (Design/Process) meetings and action requirements
• Ability to manage priorities and workflow in a rapidly changing environment
• Experience working in a cross-functional team environment
• Excellent organizational, problem-solving, and analytical skills
• Excellent verbal & written communication skills
• Good interpersonal skills
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System

Standards

Preferred:

• Working understanding of the following standards: ISO14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155
• Certified ISO 13485 Lead Auditor
• Experience with robotics/software
• Experience with Medical Device Manufacturing

COMPETENCIES

• Drives results
• Optimizes work processes
• Decision Quality
• Collaborates
• Problem Solving
• Critical Thinking
• Communicates Effectively
• Manages Complexity

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to 10 %).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.