Staff Supplier Design Quality Engineer

Johnson & Johnson Innovative Medicine•West Chester, PA

1d•Onsite

About The Position

Johnson & Johnson is currently recruiting for a Staff Supplier/Source Design Quality Engineer! This position will be located in West Chester, PA. The Staff Supplier/Source Design Quality Engineer supports new product development and design transfer activities by ensuring Supplier and Strategic Collaborator processes meet quality, regulatory, and TECA business requirements. This role leads process and test method validation, risk analysis (i.e. PFMEA), supplier qualification, and inspection planning, while applying statistical and quality engineering tools to decision-making. The position also provides quality system leadership across areas such as CAPA, nonconforming materials, complaints, inspections, and risk management, and works cross-functionally with R&D, Quality, Regulatory, Supply Chain, and Supplier/Strategic Collaborator to ensure compliance and successful product realization.

Requirements

A minimum BS degree in a mechanical engineering or related technical discipline with a minimum of 6-8 years of experience in related field is required.
Experience working in both an FDA and European regulatory environment is required.
This position will require relevant experience working in manufacturing/operations.
In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
A thorough understanding of GMP/ISO/Validation regulations (FDA 21 CFR 820 QSR, ISO 13485).
Experience with a proven track record of implementing appropriate risk mitigation.
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
The ability to perform "hands on" troubleshooting and problem solving is required.
Good technical understanding of manufacturing equipment and processes is required.
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
This candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals.
Quality-oriented mindset
Communication skills
Independency
Integrity
Able to communicate and writing skills in English (preferred)
Flexibility
Service minded

Nice To Haves

Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).
4-6 years of related experience is required
Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred
Training experience (Train the Trainer) internally and externally is strongly recommended.
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.

Responsibilities

Supports transfer to manufacturing activities both in Product Development and base business.
Conduct and lead process verification and validation activities at the supplier/collaborator.
Conduct and lead design / process failure mode effects and analysis.
Develop inspection methodology and acceptance criteria for inspection sample plans.
Provides leadership in Test Method Validation (TMV) at the supplier/collaborator.
Works closely with suppliers on the qualification of new parts and processes supporting product development.
Applies statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
Supports Gage R&R studies.
Conduct assessments of new suppliers as part of the project teams.
Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Post Market Surveillance, Nonconforming Materials, Risk Management, internal and external Inspections, etc.
Provides leadership in the understanding of medical device regulations to other disciplines.
Responsible for communicating business-related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Performs other duties assigned as needed