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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**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
- University Bachelor’ degree in science, engineering, or related field.
- 2 to 4 years’ experience in a highly regulated industry is required
- Strong knowledge of GMP/GDP, FDA/ISO regulations, and a robust Quality Management System.
- Demonstrated experience managing supplier nonconformance, CAPA, and change control processes
- Direct experience performing supplier audits and supplier quality system assessments.
- Demonstrated problem-solving skills with root-cause analysis and familiarity with CAPA processes (8D, PDCA, etc.).
Required knowledge, skills, abilities, certifications/licenses and affiliations
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Black/Green Belt, or equivalent certification is desired
Excellent written and verbal communication skills; proven ability to interact with suppliers and cross-functional internal stakeholders.
Ability leads to change, drive reliability, and foster a culture of quality and safety
#LI-Onsite
**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