Senior Source Quality Engineer

at  Johnson Johnson

Ethicon is recruiting for a Senior Source Quality Engineer, to be located in Raritan, NJ.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.
The Senior Source Quality Engineer (Sr. SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Sr SQE leads the deployment of the Source Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for Ethicon Supply Chain Suppliers.
Key Responsibilities:

Provide timely business support for the assigned Ethicon Source Quality Management (SQM) function globally.

• Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
• Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Source Quality Management. May lead this process under the guidance of Source Quality Manager and/or management representative.
• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
• Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
• Own, drive, and lead the assigned Source Quality related projects, activities, initiatives with limited supervision.
• Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
• Utilize analytical and problem-solving skills to develop and optimize supplier performance.
• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Actively participates in discussions to drive resolution.
• Collaborate with operations and franchise operations development on process/product improvement projects.
• Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Source Quality Manager and/or management representative.
• Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
• Own and lead the Source Quality Relationship Management (SQRM) process for the assigned suppliers (e.g. Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow-ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.).
• Understand or anticipate the customer’s needs and adds value by providing specific metric information tailored to the particular business environment.
• Take actions to identify internal customer requirements and translate customer requirements into potential proactive improvements to components or supplier quality systems. Proactively pursue clarification to confirm understanding of internal customer needs and requirements. Follow up on commitments and keeps customer, management and appropriate parties apprised.
• Respond proactively to changing regulatory and business needs.
• Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.
• Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements.
• Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
• 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.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

QUALIFICATIONS

Education:

• University/Bachelors or equivalent degree in Engineering, an Applied Science or a related Technical and Quality field is required.

Experience

Required:

• A minimum of two to four (2-4) years of experience in a highly regulated industry is required.
• Prior manufacturing, plant or technical background.
• Demonstrated knowledge of manufacturing principles and practices, and procedures.
• Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches.
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls.
• Experience with documentation and technical writing skills, in a regulated compliance environment.
• Demonstrated ability to identify compliance risks and assess business impact.
• Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards).
• Must have strong business acumen. The ability to collaborate with all levels of management in cross-functional team environment.
• Ability to communicate effectively in English.

Preferred:

• Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.).
• Direct experience in plant and/or supplier GMP auditing.
• Component Qualification/Process Validation experience is preferred. New product introduction experience is desired.
• Prior experience with FDA inspections.
• Broad knowledge of Quality System Regulations and Source Quality Management principles.
• Ability to manage complexity and work in a diverse team environment is essential.
• Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs).
• ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP).
• Quality Auditor qualifications or Lead Auditor certifications such as ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA).
• Flawless Project Execution (FPX) or Project Management Professional (PMP) trained and certified.
• Six Sigma Black Belt/ Green Belt (CSSBB)/CSSGB) or Lean certification from a recognized program or PE leadership training.
• Strong analytical skills, metrics development and ability to identify trends are desirable.
• Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®).
• Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin).

Other:

• This position may require up to 25% domestic and international travel.
• The anticipated base pay range for this position is $76,000 to $121,900.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Please refer the Job description for details