MGR II QUALITY

Job Overview

The Senior Quality Manager is responsible for the administration, supervision, and development of the San Rafael Quality Assurance and Quality Engineering functions The role involves actively building a high-performance culture and driving the growth and development of talent within the team. 
The role's purpose is to ensure full compliance with regulatory requirements such as 21 CFR 820, ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R sch3, MDR, and other applicable regulations, including production and process controls.

The Senior Quality Manager will report to the Global Head of Quality Operations.

Manages the business unit's quality management system, promotes zero defect culture and delivers consistent and reliable operational performance.

Job Requirements

• Duties & Responsibilities:

  •Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.

  •Develop and implement systems to assure that development as well as production teams receive support in the following areas:
      - Quality planning, including inspection techniques and sampling methods
      - Statistical Analysis
      - Biological testing 
      - Application of required regulatory standards
  •Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications.  These systems are to include as a minimum:
      - Delivery of raw materials and components
      - Manufactured devices and equipment
      - Documentation associated with these functions
  •Leads performance management, develops talent and coaches the team.
  •Support regulatory agency and customer quality audits. 
  •Ensure the conformity of the components and devices are appropriately checked in accordance with the Quality Management System before release.
  •Responsible for assisting and training associates in concepts of probability and statistics.
  •Responsible for failure appraisal and analysis (internal and external).
  •Authority to place products or processes on hold.
  •Design and develop forms and instructions for recording, evaluating, and reporting quality data.
  •Corrective and Preventive Action program
  •Based on operational/quality requirements, assist in test equipment selection and validation.
  •Utilize formal problem-solving techniques to resolve product and/or process related issues.
  •As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.
  •Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
  •Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards. 

• Overseeing the quality control documentation, effectiveness reports, checklists, logs, relevance, and accuracy, assessing the results, and giving recommendations.
• Leading the initiation and follow-up of corrective action requests and preventive measures to keep quality programs within targeted budgets.
• Ensuring that the product meets quality and efficiency standards, devising ways to improve the associated processes, and producing high-quality goods.
• Developing product quality plans, associated statistical control monitoring, and driving process control initiatives to improve yield, quality, and reliability.    

What your background should look like

Education/Experience:

•Degree with a scientific or engineering emphasis.
•ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.
•Minimum of ten (10) years experience in a related regulated environment.
•Experience should include positions at senior levels within the medical device organizations.
•Proven experience leading teams within a manufacturing environment
Key Requirements:

To perform this job successfully, an individual should demonstrate the following competencies: Analytical, Design, Problem Solving Project Management, Technical Skills, Interpersonal Skills, Oral and Written Communication Skills, Teamwork, Judgment Motivation and Planning/Organizing Professionalism, Adaptability, Dependability, Initiative, Excellent computer skills Highly Motivated with a sense of urgency and be Proficient in the use and application of advanced statistical methodologies.  
•Ability to implement robust performance management systems. 
•Strong coaching and mentoring abilities.
•Building effective teams
•Values:  Integrity, Accountability, Inclusion, Teamwork, Innovation
•SET:  Strategy, Execution, Talent (for managers)

SUPERVISORY RESPONSIBILITIES: This position has Quality Manager(s), Senior Quality Engineers, and Quality Engineers reporting directly or indirectly to it.

Direct Responsibility: All quality functions of Quality Operations, Validation & Calibration Engineering and Microbiology, 

TRAVEL:  This position may require up to 10% travel TE sites and customer locations as required, dependent on the needs of the organization    

Competencies