Quality Assurance and Regulatory Affairs Manager

hace 2 semanas

Tijuana, Baja California, México Ivemsa A tiempo completo
Job Title: Quality Assurance and Regulatory Affairs Manager

The Quality Assurance and Regulatory Affairs Manager will play a crucial role in driving the strategic and operational performance of the Quality department at Ivemsa. This position ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost, and delivery, while facilitating continuous improvement and achieving commercial success.

The Manager will lead and manage the quality team and ensure the efficient and effective day-to-day running of the department. They must be a change agent and possess hands-on management skills.

Key Responsibilities:
  • Assist in developing and/or executing strategic plans to meet departmental and organizational goals while complying with regulatory and customer requirements.
  • Lead, develop, and coordinate the requirements necessary to meet ISO, FDA-GMP, and customer audit compliance in the most cost-effective manner.
  • Manage the routine activities of the Quality Laboratory, including personnel selection, development, evaluation, motivation, and retention, as well as operation within budgetary constraints.
  • Administer and coordinate the Customer Complaint System, ensuring timely communication with customers, sales, manufacturing, engineering, and other personnel.
  • Continually partner with Product Development Engineers and customers to develop specifications, ensuring customer requirements and company specifications match.
  • Provide leadership and guidance to ensure corrective actions are resolved, adequate root cause analysis is completed, and short- or long-term corrective actions are implemented.
  • Ensure strong communication with complaint responses or other Q.A. concerns with other departments, facilitating exchange of information to implement change and improvements regarding quality.
  • Identify and proactively lead continuous improvement actions to prevent non-conformances, working closely with internal and external customers.
  • Provide progress reports/Quality Key Performance Indicators (KPIs) to Senior Management.
  • Develop, implement, and maintain Quality Systems.
  • Drive key performance indicators to all levels within the organization related to Quality Assurance and participate in making recommendations for necessary changes to enhance business objectives.
  • Prepare and conduct formal management review meetings and follow up.
  • Responsible for publishing and approving documents, maintaining and continuously improving quality system processes as required by international, regional, and national regulatory authorities and standards, ISO 9001, and FDA QSR.
  • Function as the management representative during audits, internal and external.
Requirements:
  • 10 to 15 years of experience related to Quality/Regulatory System Development and Management.
  • 5+ years of experience working in an FDA-regulated environment.
  • 5 to 10 years of experience managing people.
Skills and Abilities:
  • Understanding of FDA's Quality System Requirements, 21 CFR 820, ISO 9001, and ISO 13485.
  • Knowledge of other regulatory processes: 510K, DMS, DMR, DHR, process validation, and statistical quality tools.
  • Understanding and knowledge of working in a clean room manufacturing environment.
  • Excellent oral and written communication skills.
  • Excellent leadership skills.
  • Knowledge of lean manufacturing, Six Sigma, and team problem-solving.
Working Conditions:

Full-time position, indefinite contract.

Salary: $120,000.00 - $140,000.00 per month.

Working hours: Monday to Friday.

Benefits:

  • Salary increases.
  • Company parking.
  • Option for indefinite contract.
  • Medical expenses insurance.
  • Major medical expenses insurance.
  • Dental insurance.
  • Company phone.
  • Additional vacation days or paid leave.
  • Meal vouchers.

Compensation types:

  • Annual bonus.
  • Productivity bonus.
  • Punctuality bonus.

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