Senior Quality Systems 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:

Quality Assurance

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 Senior Quality Systems Engineer.

Purpose:
Provide high performance quality system guidance and support for development, maintenance and enforcement of compliance of the company Quality Management System. The Senior Quality Systems Engineer will collaborate closely with business partners to provide leadership regarding the Quality System Standardization activities ensuring the site is compliant with franchise procedures and external standards & regulations.

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:

• Will serve as a Quality Systems subject matter expert, track and report action plan status/ completion as relates to quality systems improvement efforts. 
• As needed, assist with creation, modification and improvement of Quality System procedures, work instructions and related documentation.
• Drive robust quality and compliance execution in the business and drive successful Q&C scorecard metrics by working closely with key stakeholders in the business.
• Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, Non-Conformance, and subsequent closure of investigations.
• Oversee all Compliance activity within the facility in conjunction with the Regulatory Compliance and Quality Operations groups. Liaise with management at all levels of the business and produce metrics and present data on site performance at meetings such as the weekly and monthly management meetings
• Oversee the Customer Complaints system in conjunction with Complaints and Vigilance Manager, ensuring that timely closure is met whilst fully satisfying all Customer Complaint requirements.
• Ensure that the Quality System Review (QSR) continues to develop in terms of inputs and to ensure that any trends noted at this forum are challenged and acted upon
• Responsible for conducting training in Quality Systems Management principles to business partners
• Facilitates process of product issue assessment, quality review board preparation, and field action execution.
• Facilitates technical innovations to enhance Quality Systems and support business goals.
• Provides back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).

• Serves as a SME on the Quality Planning process, assists Quality Plan authors with the process, and files Quality Plans
• 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 Minimum Education: University Bachelor’s Degree or Equivalent (preferably in Engineering, Math, Science, or Business)
• 4-6 years’ experience in Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience.
• Minimum of 4+ years’ experience in an FDA regulated industry (medical device, pharmaceutical, etc.).

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

• Working knowledge of 21 CFR Part 820, 21 CFR 806, ISO 13485 and familiarity with ISO 14971.
• Broad-based technical knowledge and experience to work effectively with others in diverse areas of business (Operations, Quality, R&D, R.A., Engineering). 
• Ability to effectively prioritize and manage multiple activities and responsibilities.
• Must have outstanding business and technical communication skills (verbal, written, presentation)
• Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.) preferred
• Proficiency with quality-related statistical applications such as those for Minitab.
• American Society for Quality (ASQ) credentials preferred
• Experience leading teams and with change management activities
• Bilingual (English and Spanish)

Required Skills:

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)