Empleos de order manager en Jalisco

At Benchmark, we are driven by our purpose: to innovate for a healthier, safer, and better-connected world to create a brighter future. When you join us, you become part of a team passionate about making a meaningful impact across various sectors, including commercial aerospace, defense, advanced computing, next-generation communications, complex industrials, medical, and semiconductor capital equipment. We prioritize career growth, fostering a culture that ensures you reach your full potential. At Benchmark, your work is purpose-driven, enabling you to create a positive impact on the world and make your career truly meaningful. You’ll be part of a collaborative, diverse, and inclusive team that values your ideas and contributions.

Summary: The Regulatory and Compliance Manager oversees compliance to applicable regulatory and legal requirements for medical devices by defining policies, and procedures for compliance, conducting various activities to communicate, effectuate, and ensure compliance with such requirements. Defines and reviews validation requirements and plans for the site to ensure that all validation activities are delivered in compliance with Benchmark policies and procedures and per the guidance and requirements of the CFR, ISO and international regulations. This position reports to the site general manager and US corporate, will be located in our San Jorge site.

Responsibilities:

Validation Process:

• • Responsible for maintaining the validation program in an audit ready state and in accordance with current regulations and in alignment with Benchmark Corporate procedures.
  • May act as a Local Subject Matter Expert / Trainer for process validation to the team involved in process validation. May act also as Subject Matter Expert for internal or external customers.
  • Mentor and support staff by providing training and technical guidance in decision making, determining validation strategy.
  • Reviews and approves validation plans, protocols, and reports.
  • Support product transfers/new product development. Ensure integration of validation schedule in production schedule for implementation of validation activities

Regulatory:

• • Primary contact and resource during FDA inspections; conducts regulatory activities and interacts with FDA and/or other regulatory agencies to ensure compliance.
  • Researches, identifies and keeps updated on outside medical regulations, update processes where necessary, and communicates requirements, updates/changes affecting the quality system to concerned parties.
  • Identifies and coordinates the submission of all pertinent information for new medical device product approval and monitors the regulatory status of new product developments.
  • Maintains compliance of process and system procedures to FDA/QSR requirements and analyzes audit and performance results to identify deficiencies and improvement opportunities.
  • Regulatory Designate for review and approval of all applicable regulated device documentation.
  • Review and approval of Regulated devices frameworks.
  • Verifies medical device manufacturing per the Medical Devices Regulations.
  • Approves validations for manufacturing of regulated devices.
  • Approves change control of documents related to the manufacturing of regulated devices.
  • Review and consult on new and ongoing projects for regulated products to ensure the schedule and regulatory decisions made are compliant to FDA and customer requirements.
  • Reviews and approves of corrective and preventive actions from audits and customer complaints related to regulated devices utilizing strong problem-solving skills, resulting in effective, compliant actions. Provided training on problem solving techniques and tools for cross functional groups.
  • Reviews and authorizes disposition of nonconforming materials for regulated devices.
  • Assess and approves any change to process, documentation, equipment, etc. in order to confirm no impact to validated state.
  • Plans, schedules, directs, evaluates, and manages the work assignments to meet the department goals in terms of quality, productivity and efficiency. Also develops, implements and maintains resource planning tools in order to project staffing needs and manage cost

Skills:

• • 4-year College Degree or equivalent combination of education and experience
  • 8+ years of quality and regulatory experience with proven experience on Validation processes; 3+ years in a leadership role in a multiple or large site (600+ employees and associated revenue/customer base) preferably with SMT and assembly manufacturing experience.
  • Possess and maintain technical expertise and knowledge of ISO type Quality Systems, specifically those supporting QSR, FDA and Medical requirements as applicable to contract manufacturing of electronic devices
  • Ability to interpret, understand and communicate regulatory requirements as applicable to the site, serving as topic expert as required in support of the corporation
  • Capable of training validation, regulatory and quality system requirements, concepts, auditing methods and quality procedures as required
  • Ability to provide day-to-day work direction for Production/Process Auditor team leaders
  • Effective customer interface skills
  • Effective communication and presentation skills
  • Ability to work with minimal supervision and guidance
  • Effective interpersonal skills

Note: We are hiring from anywhere in Mexico, but the selected candidate must relocate to Guadalajara.

Más información sobre Benchmark Mexico: https://linktr.ee/benchmarkmx