Job Description

Sterilmed, part of the Johnson & Johnson family of companies, is recruiting for a Senior Quality Engineer located in Plymouth, MN.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide.

Together, we are working to shape the future of health through differentiated products and services.

The Senior QE will provide overall quality assurance leadership in the management of select New Product Development project or legacy product engaged in the development or sustenance of Johnson and Johnson medical device products. Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards.

KEY DUTIES AND RESPONSIBILITIES:

Develop measurement systems to monitor effectiveness of QA and reliability systems to

identify, bracket, correct and prevent defects to demonstrate continuous improvement

to management

Maintain alertness to changes in the industry and regulatory environments and apply

this information to business practices

Provide support and expertise in the implementation and enforcement of GMP, ISO and

FDA (Food and Drug Administration) requirements

Prepare QA (Quality Assurance) system and assist in technical issues for manufacturing

processes that are to be transferred to satellite facilities

Manage established processes in support of steady state manufacturing in accordance

with defined QA program for product transfers

Provide statistical support and expertise in DOE (Design of Experiments) and analytical

problem solving for manufacturing, technical services and product development in order

to:

o Minimize sample and scrap waste

o Assess reliability and risks based on data presented

o Identify root cause of problems

o Reduce and identify sources of variation

Audit and approve manufacturing, quality, engineering and validation / qualification

documents for conformance to company business practices and departmental

procedures

Support development of validation strategy
Act as liaison to Regulatory Affairs department to perform initial regulatory review of all

engineering changes / modifications to products

Perform analysis of documents / information to ensure that all critical product

characteristics have been identified and properly evaluated:

Design specification
FMEA (Failure Mode Evaluation and Analysis): Product and Process Material

Specification

FGI I Sheet / P-Sheet
QA system (in line control points) - FGI results
Product inquiry analysis
Reliability analysis
R&D Laboratory and other product development support, including plans,

reports, product/sample records, as required

Provide sampling plans and approve inspection, methods for evaluation and testing of

components and products

Support Continuous Release program, where applicable to reduce need for FGI

inspection

Provide support and expertise in reliability strategy and reliability growth demonstration

during new product development

Responsible for communicating business related issues or opportunities to next

management level

For those who supervise or manage a staff, responsible for ensuring that subordinates

follow all Company guidelines related to Health, Safety and Environmental practices and

that all resources needed to do so are available and in good condition, if applicable

Responsible for ensuring personal and Company compliance with all Federal, State, local

and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualifications

A minimum of a Bachelor’s degree required, preferably in Engineering or related technical field
A minimum of 4 or more years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required
Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is required
Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and Test Method Validation (TMV) is required
Ability to develop and implement Quality standards is required
Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices is highly preferred
Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is required
Demonstrated problem solving skills is required
Good understanding of theoretical and practical fundamentals and experimental engineering techniques is required
Fundamental technical understanding of manufacturing equipment, processes, and validations standards (IQ/OQ/PQ and TMV) is required
Competent using MS Office (word, excel, power point, outlook, etc.) is required
Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes is required
Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments is required
Ability to multi-task and manage multiple assignments in a timely manner is required
Good verbal and written communication skills is required
Strong interpersonal and leadership skills is required
Strong analytical skills is required
Ability to apply project management skills to ensure fulfillment of new product development requirement is preferred
Experience with Minitab, R or other statistical software is preferred
Experience working in both an FDA and European regulatory environment is preferred
A thorough understanding of GMP/ISO regulations and validation regulations is preferred
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred
Six Sigma Green/Black Belt Certified is preferred
Ability to travel up to 10%, international and domestic is required