Quality Engineer – Medical Devices, Design Control & Risk Management

Knowledge of Quality Management Systems and applicable quality tools and techniques

Knowledge of GMP, FDA Quality System requirements, ISO 13485 and applicable compliance regulations

Knowledge of medical device regulatory standards, including design control and risk management requirements

Knowledge of NC, CAPA, deviation, Root Cause Analysis, change control and audit processes

Knowledge of statistics, Risk Management, Design Control and process validation

Experience creating and reviewing DFMEA, PFMEA, risk management records, protocols and technical reports

Experience with verification and validation documentation and IQ/OQ/PQ activities

Experience with Post Market Surveillance and quality trend evaluation

Experience with PLM/eQMS tools; Windchill experience is preferred

Good understanding of engineering drawings, specifications, tolerances and GD&T

Experience supporting neurovascular, catheter-based, implantable or other Class II/Class III medical devices is

preferred Strong written and verbal communication, problem-solving, planning and project-management skills Proficiency with word processing, presentation, e-mail and spreadsheet software Ability to manage multiple priorities, meet timelines and communicate project status clearly Experience preparing and maintaining Quality Plans Experience supporting technical transfer (tech transfer) and manufacturing transfer activities Experience providing QMS support, including internal/external audit and CAPA support Experience writing and revising Quality SOPs and Work Instructions (WIs)

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and

Corporate Johnson & Johnson procedures and guidelines, the duties and responsibilities for this position are:

Provide quality engineering support for Cerenovus neurovascular products throughout product development,

design changes, technical transfer (tech transfer), manufacturing transfer and sustaining activities

Prepare, develop, review, maintain and approve Quality Plans and Product Development Process deliverables,

including protocols, reports, specifications and engineering documentation

Review and approve R&D/Engineering verification and validation protocols and reports

Develop and maintain risk management records, including DFMEA and PFMEA, in collaboration with subject

matter experts

Support and provide quality guidance for process validation and equipment qualification activities, including IQ,

OQ and PQ

Provide Quality Management System (QMS) support and maintain Quality documentation to ensure objective

evidence is complete, accurate and traceable

Lead or support audits, Root Cause Investigations and closure of nonconformances, deviations and CAPAs;

support audit responses and verify effectiveness of implemented corrective and preventive actions

Review and approve Change Orders, including CR/CN documentation, and assess product, process, quality

and regulatory impact

Apply statistical methods to process and product data, including capability analysis, sampling rationale and

measurement system assessment, as applicable

Support post-market quality activities, complaint trending and design or process enhancements

Write, review, revise and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) for

Quality functions

Interpret new or upcoming quality and regulatory requirements and provide guidance to cross-functional teams

Partner with R&D, Manufacturing, Regulatory, Operations, Supplier Quality and other internal teams to create

and approve deliverables

Perform other duties assigned as needed

Generic Managerial Skills, If any

• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.

• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide

responses satisfactorily and with immediacy is required.

• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.

• Ability to understand and follow complex written procedures is required.

• Ability to function in a team environment and deliver on team objectives is required.

• Ability to make decisions and solve problems while exhibiting situational judgement.

Key Words to search in Resume

Senior Quality Engineer, Medical Device, Neurovascular, Cerenovus, Design Control, GMP, ISO 13485, ISO

14971, CAPA, Nonconformance, Statistics, DFMEA, PFMEA, Risk Management, Root Cause Analysis,

IQ/OQ/PQ, Process Validation, V&V, GD&T, Windchill, Manufacturing Process, Quality Plan, Tech Transfer,

QMS, Audit Support, SOP, Work Instruction

Pre-Screening Questionnaire

• How many years of quality engineering experience does the candidate have in the Medical Device or

regulated life sciences industry? A minimum of 5 years is preferred.

• Does the candidate have experience with Design Control and Product Development Process deliverables?

• Does the candidate have experience creating or reviewing Risk Management records, DFMEA and PFMEA?

• Does the candidate have experience reviewing V&V protocols and reports?

• Does the candidate have experience supporting process validation activities, including IQ, OQ and PQ?

• Does the candidate have experience with NC, CAPA and structured Root Cause Analysis?

• Does the candidate have knowledge of engineering drawings, tolerances and GD&T?

• Does the candidate have experience with Windchill or another PLM/eQMS system? • Does the candidate have neurovascular, catheter-based or Class II/Class III medical device experience? • Is the candidate willing and able to work from the El Paso or Irving, Texas location?