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: **
Business Process Quality
Job Category:
Professional
All Job Posting Locations:
Juarez, Chihuahua, Mexico
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
About Surgery
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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for Staff Process Quality Lead
Purpose:
- The Process Quality Lead position is established to enhance the Quality activities on the business unit, such as nonconformances, complaints, attend internal and external audits, audit observations resolution, quality indicators, escalation processes, CAPAs, DRB, PQSS and any quality issue affecting the business unit
- Promote Quality Culture in Operations and Lead & engage strategies for risk management.
You will be responsible for:
Responsibilities may include, but are not limited to:
- Develop and supervise effective defect tracking mechanisms and coordinate improvement actions.
- Lead efforts and projects to improve quality performance for the Business Unit, including In-Process Reporting, Software Upgrades to systems, etc.
- Lead quality system improvements, which result from internal audits, QLT, and Quality Board Issues, as required.
- Responsible for the appropriate execution of Quality Assurance test methods and inspections procedures of raw material, work in progress and finished product for the Business Unit.
- Establish and maintain programs, procedures and controls ensuring that product and raw materials are manufactured and controlled as per established procedures, specifications, medical device regulations, sterilization guidelines, and ISO standards.
- Support cost savings opportunities that work toward achieving the objectives of the Business Unit.
- Responsible for ensuring compliance with procedures for all nonconforming product and raw materials applicable to the Business Unit.
- Support projects and new product introductions by establishing key checkpoints for new products and processes.
- Ensure compliance with company policies and procedures.
- Promote the use of quality metrics and performance data to drive improvements.
- Support efforts in the use of Process Excellence tools to enhance analytical thinking and problem-solving techniques.
- In depth knowledge and analysis of voice of the customer (product complaints) and lead process improvements in collaboration with Engineering and Manufacturing to reduce or eliminate Product Complaints.
- Active participant in CAPA council boards (plant and franchise) and Management Review to identify and lead process improvements to reduce or eliminate complaints.
- Establish a process to assess the use of internal quality data as a predictor to reduce/eliminate product complaints.
- Work with Materials Planning and Manufacturing to facilitate testing and release of product.
- Review and participate in personnel development programs necessary to provide employee movement through prescribed promotional patterns.
- Evaluate and recommend staffing requirements to optimize the utilization of personnel to fulfill Business Unit objectives.
- Responsible for the coordination of Business Unit activities with QA partners for corrective and preventive actions.
- Acts as CAPA owner and coordinator as determined by the Business Unit Manager or Director.
- Acts as Risk Escalation Owner to drive investigation and communication to Risk Management Board.
- In conjunction with QA partners, prepares presentations for QLT and QB meetings and represents the Business Unit in CAPA reviews.
- Track and monitor CAPA metrics for the Business Unit and drives actions for improvement.
- Lead improvements in quality performance metrics for the Business Unit such as responses to internal and external audits, NCR, QNC, compliance training, etc.
- Ensure compliance to the quality policy in all activities
- Promotes Quality Culture in Operations by facilitating trainings, quality talks and other engagement strategies.
- Support and promote the safety and industrial hygiene objectives of the site.
Qualifications / Requirements:
Experience in Medical Device Industry preferred
A Minimum of BS in Engineering
CQE (ASQ) Certified, preferred
Certification in Lean Manufacturing or Six Sigma is preferred
Include Senior Process Quality Leader duties in addition
Lead investigation in Escalations delivered to QRB and conducts complaint handling investigations.
Utilizes statistical analysis and process excellence tools to troubleshoot and solve quality issues.
Deliver clear communication to Medical Safety Officer for HRE Assessment.
Maintain Clear communication to Regulatory affairs for Regulatory assessment
The Staff Process Quality Lead is an emerging authority leading Plant or Franchise wide engineering and manufacturing quality improvement strategies.
Staff PQL must have excellent communication and written skills to lead a large multifunctional group to positively impact plant quality metrics.
Connect and Lead Quality Initiatives for critical QA Metrics.
Provide strategic guidance to BU Manager, Plant Manager and Plant QA Management – keep them well informed of all major problems, improvement activities & potential barriers.
Interface directly with operations and quality management to ensure that manufacturing operations & projects receive superior technical support and foster highest standards of quality and compliance.
Assures all products conform to existing quality requirements by following the standard operating procedures, and government regulations and adheres to all good manufacturing practices.
Participates and/or lead quality investigations and/or internal audits to assess conformance to specifications, company procedures, and overall compliance to regulations.
Staff PQL must have excellent communication and written skills to lead a large multifunctional group to positively impact plant quality metrics.
Generally, requires 6-8 years related experience
Provide strategic guidance to BU Manager, Plant Manager and Plant QA Management – keep them well informed of all major problems, improvement activities & potential barriers Interface directly with operations and quality management to ensure that manufacturing operations & projects receive superior technical support and foster highest standards of quality and compliance.
Assures all products conform to existing quality requirements by following the standard operating procedures, and government regulations and adheres to all good manufacturing practices.
Participates and/or lead quality investigations and/or internal audits to assess conformance to specifications, company procedures, and overall compliance to regulations
Staff PQL must have excellent communication and written skills to lead a large multifunctional group to positively impact plant quality metrics.
Proven initiative, creativity, assertiveness and leadership skills.
Must be able to work under pressure achieving consistently high results through individual and team efforts.
Master’s Degree (preferred)
Excellent interpersonal, influencing, communication, presentation, listening, and negotiation skills
Ability to set priorities and achieve objectives.
Excellent analytical and statistical skills.
Proven skills in root cause analysis, problem resolution and documentation practices.
**Required Skills: **
Preferred Skills:
Business Process Management (BPM), Business Requirements Analysis, Business Savvy, Coaching, Communication, Compliance Management, Cross-Functional Collaboration, Data Savvy, Fact-Based Decision Making, ISO 9001, Leverages Information, Operational Excellence, Problem Solving, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Standard Operating Procedure (SOP)