Quality Operations Manager

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At **Johnson & Johnson MedTech **, **we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

**We are searching for the best talent for Quality Operations Manager to be in San Jose, Costa Rica**

**Purpose**:Plans, coordinates and directs the quality assurance programs designed to ensure the continuous production consistent with the established standards through the following responsibilities, either personally or through his/her subordinates.

**You will be responsible for**:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Leads or support quality improvement initiatives, such as the characterization of processes and products that leads to continuous improvements / cost.
- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
- Performs benchmarking in order to develop more effective methods to improve quality.
- Establishes and formulates the quality metrics to maintain the quality assurance objectives and alignment with the objectives of the plant.
- Supports the development of quality engineering and the compliance with the quality with the adequate abilities for the introduction of new products and product life cycle management.
- Promotes and supports the implementation of quality, product and process improvement projects.
- Revises and approves Engineering Change Orders (ECOs).
- Evaluation, monitoring and analysis of the quality costs in order to maintain a quality system
according to the medical industry standards.
- Revises / analyzes if the current products and processes (including performed actions or decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.
- Leads the preparations activities for regulatory agencies audits, including the active participation as “SME” or “Escort” (for example: FDA, JJRC, BSI, etc.).
- Revises and approves the answers to internal and external audit observations ton ensure the compliance with the internal procedures and applicable regulations.
- Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems.
- Ensures the performance of periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the results of the audits of the area to ensure that the corrective and preventive actions are adequate.
- Defines, monitors and administers the central budget of the department/cost
- Collaborates with NPI and with the operations and engineering departments to develop, conduct and approve validation strategies of products and processes.

**Qualifications**:
**Qualifications**:

- As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable
science.
- Master or Doctorate in applicable sciences, preferable.
- 8 to 10 years of work experience, or demonstrated performance
- Use of computer packages.
- Ability to effectively deal and negotiate with representatives of various governmental agencies and auditing agencies.
- Excellent communication skills in English, spoken and written.
- Ability to perform “active involvement” in the solution of problems and resolution of problems, preferably.
- Capacity to solve problems providing good judgment is highly desired.
- Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus.