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Posted 5d ago

Manager, Global Quality Systems

@ Confluent Medical Technologies
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Alajuela, Alajuela, Costa Rica
OnsiteFull Time
Responsibilities:coordinate audits, lead audits, manage CAPA
Requirements Summary:Bachelor in Engineering or Life Sciences; 7+ years in Process Validation in regulated medical devices; 3+ years in leadership; Lean/Six Sigma; ISO 13485/FDA knowledge; strong analytical and audit skills.
Technical Tools Mentioned:QMS software, Lean, Six Sigma, Statistical analysis
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Job Description

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry's most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.

We are looking for Manager, Global Quality Systems to join our team in Costa Rica.  As a member of the centralized Global Quality Systems team, the Quality Systems Manager oversees Quality Systems activities at Confluent, including Training, Supplier Management, customer audits, and Document Control. The role identifies and recommends quality system improvements based on assessments performed and provides compliance guidance to the organization, as needed. The position exercises judgment within established procedures and practices to determine appropriate actions, participates in decisions regarding scope and timelines, and reviews, documents, approves, and implements applicable requirements. This role leads problem resolution within the defined scope, works independently on routine activities, and coordinates cross-functional support to resolve complex issues. The position also oversees post-manufacturing activities and product release to customers; supervises document control processes; manages administration and follow-up of the CAPA system; oversees supplier quality processes; and supports Regulatory Affairs.

Travel to the U.S. is required approximately 25% of the time.

SUPERVISORY RESPONSIBILITIES:

Supervises:

  • Document Control Clerk
  • Quality Release Technician III
  • Quality Systems Engineer
  • Quality Assurance Technician

ESSENTIAL DUTIES AND RESPONSIBILITIES may include the following (other duties may be assigned):

  • Coordinate internal and supplier audits to ensure compliance with regulatory (GMP/QSR/ISO) and company requirements.
  • Partner with the Supplier Quality Manager to maintain an effective supplier audit program.
  • Assign and track CAPAs, classify audits, and document results in formal reports.
  • Serve as Lead Auditor, directing audit teams and mentoring auditors-in-training.
  • Manage the audit training matrix and support training related to audit findings.
  • Administer the Quality Management System (QMS) database and maintain audit records and responses.
  • Support and escort external auditors from regulatory agencies, customers, and suppliers.
  • Conduct cross-site audits and provide guidance to audit team members.
  • Monitor compliance metrics and generate reports for management review.
  • Stay current with regulatory changes and industry standards.
  • Ensure compliance with Health, Safety, and Environmental (HSE) guidelines and that resources are properly maintained.

EDUCATION and/or EXPERIENCE:

  • Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
  • Advanced English proficiency (B2+), both written and verbal.
  • 7+ years of experience in Process Validation within a regulated industry (medical device required), with strong statistical knowledge.
  • 3+ years of leadership or people management experience.
  • Solid expertise in Lean manufacturing, Six Sigma, and process improvement methodologies.
  • Proven experience managing global or multi-site quality systems.

Skills & Competencies:

  • In-depth knowledge of QMS regulations and standards (ISO 13485, FDA 21 CFR Part 820, etc.). required - medical
  • Strong leadership, communication, and stakeholder management skills.
  • Proven ability to drive process improvements and change management initiatives.
  • Excellent analytical, problem-solving, and decision-making capabilities.
  • Experience with audit management and regulatory inspections.
  • Proficiency in quality systems tools and software.

Preferred Qualifications:

  • Certified Lead Auditor (ISO 13485 or equivalent).
  • Experience in global organizations with multi-site operations.
  • Familiarity with digital QMS platforms and system implementations.

This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.