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Gerente Senior de RAQA in São Paulo at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

The RAQA Manager analyzes, implements and maintains quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Ensures the quality assurance programs and policies are maintained and modified regularly.

Key responsibilities include: 

1. Compliance

Must conduct all businesses and affairs in compliance with the laws and the regulations, including with the Foreign Corrupt Practices Act (FCPA) and the Stryker Code of Conduct, in compliance with the highest ethical values.

2. Regulatory Affairs:

•         Responsible for developing, modifying and executing regulatory guidelines related to the company and procedures.

•         Maintains current and new products registered according to local regulatory policies

3. Quality Assurance

•         Defines, specifies and/or approves the application of standards, methods and procedures to inspect, test and evaluate the precision, exactness and trustworthiness of the products of the company.

•         Supports the international recall process.

•         Responsible for the analysis of failures associated with the system of management of claims, including the documentation of failures, causes of failures and identification of corrective actions.

•         Leads compliance audits in Quality Assurance and communicates the results.

•         Certifies MDR inspections and registers, communicates inspections motivated by claims of representatives of sales/customers, carries out regulatory internal audits and quality, analyzes if the claims are concluded and evaluated, in compliance with the regulatory requirements.

Conduct and compliance:

Abide by and support the policies set forth in the Stryker Code of Conduct;
Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker

Academic qualifications / degree & relevant prior experience: 

• Bachelor’s Degree in Engineering or Sciences;

• Previos experiences as manager in a function of quality control/regulatory affairs  or equivalent experience.

•  Fluency in English; Spanish is desirable

•  Concluded formal training in Quality Guarantee;

Key strengths / personal attributes for the role:

  • Demonstrated attention to detail and quality;
  • Ability to work effectively with customers and cross-functional teams in fast paced environment;
  • Ability to work within a team and resolve problems using independent decision making skills;
  • Excellent verbal and written interpersonal communication skills;
  • Demonstrated relationship skills;
  • Effective analytical skills;
  • Excellent organizational skills;
  • Proficiency in Microsoft Office (Word, Excel, Powerpoint).

Travel Percentage: Up to 25%


Work From Home: No

Travel Percentage: Up to 25%

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