Experienced Supplier Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Grecia, Costa Rica

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Experienced Supplier Quality Engineer.

Purpose:
The Source Quality Engineer is responsible for ensuring the quality, compliance, and continuity of materials, components, and outsourced manufacturing/processes that support medical device products. This role leads to supplier qualification and performance management activities, drives supplier corrective actions and continuous improvement, and partners cross-functionally to mitigate supply risk and support product launches and lifecycle changes in a regulated environment and according to internal procedures.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Provides quality engineering leadership in the management of select contract manufacturing and supplier sites engaged in the production and delivery of Johnson and Johnson products and services.
• Responsible for technical leadership in establishing quality expectations at the supplier, to include process changes in partnership with Source Quality and New Product Development (NPD) Teams
• Partner with NPD team to support successful launches at suppliers.
• Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO and other applicable standards.
• Provide product team support for quality system requirements and supplier auditing, compliance assessment, and for support of sustaining manufacturing processes.
• Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management
• Address and support investigation of product issues to include product and processing complaints.
• Apply industry and process excellence tools and standards in daily quality operation activities, to include Good Manufacturing Practices (GMP), equipment engineering system (EES), and ISO.
• Report on supplier performance metrics during quality and management reviews.
• Lead supplier visits to assess compliance to process excellence standards.
• Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability. Identify, bracket, correct and prevent defects. Present reports to management.
• Evaluating and implementing improved manufacturing engineering performance management systems and tracking tools, as well as facilitating resolution of complex technical, quality and operational problems

• 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.
• 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 / Requirements:

Experience and education

Required knowledge, skills, abilities, certifications/licenses and affiliations

• Ability leads to change, drive reliability, and foster a culture of quality and safety

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Coaching, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Data Compilation, ISO 9001, Issue Escalation, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection