Job Description

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:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Alajuela, Costa Rica

Johnson & Johnson is hiring for a Quality Compliance Specialist II to join our team located in Shockwave Medical Costa Rica.

The Quality Compliance Specialist supports Shockwave Medical’s processes for Quality including management of associated procedures ensuring compliance with regulatory requirements and industry standards.

Under supervision, may lead/support collaboration with various functional areas, partners with colleagues across Shockwave sites, to ensure compliance is established and maintained.

Provides support to quality system, quality system initiatives and audits of quality system.

Essential Job Functions:

• Escalations Management
  • Coordinate and manage escalated quality issues from various departments.
  • Provide support in guiding thorough investigations for escalated issues.
  • Track and process issue stages and documentation.
• Field Actions
  • Support the planning and execution of field actions in response to quality issues.
  • Collaborate with cross-functional teams to ensure timely communication and resolution of field actions.
  • Monitor the effectiveness of field actions and report on outcomes.
• Quality Planning
  • Assist in the development and execution of quality plans that align with organizational objectives.
  • Track, monitor and report on quality plan status for the organization.
• Gap Assessments
  • Conduct/assist on standard gap assessments between current practices and alignment with industry standards and regulations.
  • Support the development strategies to close identified gaps in quality standards.
  • Collaborate with relevant teams to implement necessary changes and monitor progress.
• Stay updated on industry trends and regulatory changes affecting quality standards.
• Develop and maintains local standard operating procedures to follow all FDA/EU/ISO regulations, as well as Corporate quality standards and policies.
• Develop and provide training and support to staff on quality processes and improvement initiatives.
• Participate in cross-departmental quality improvement projects and initiatives, as needed.
• Support investigations/actions associated with non-conformances and CAPA.
• Address any ad-hoc quality-related tasks that arise to support continuous improvement efforts.
• Plan and coordinate quality events, including timelines, logistics and budgets.
• Support Quality department objectives to meet the organizational goals, quality system improvement initiatives as directed by Quality manager and performs other related duties as assigned by management.
• Support quality systems audits (internal and external) including follow-up support on investigations and actions taken to address audit findings.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Other duties as assigned

Requirements:

• Bachelor’s degree in relevant discipline.
• Three (3) years of experience in a GxP manufacturing or similar regulated environment.
• English language fluency
• Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part 820 & Part 11 and ISO13485 requirements.
• Ability to work independently and/or collaboratively to complete work assignments and tasks.
• Manage time, assignments, projects and tasks in a methodical manner to ensure scheduled and planned deliverables are completed on-time and accurately.
• Strong technical writing and computer skills
• Excellent communication, leadership, and problem-solving abilities
• Flexibility to support and manage multiple assignments and associated tasks.
• Supportive of innovation, customer-focused improvements, and participating in such efforts.
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Employee may be required to lift objects up to 25lbs or more.
• Travel: May require travel (up to 10%) to support business, as needed.

Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing