Sr Manager Quality
hace 2 semanas
**Vacancy Name**
- Sr Manager Quality
**Location of Work**
- Tijuana, Mexico
**Employment Type**
- Full Time Employee
**Job Purpose Summary**
The Sr Manager Quality leads mass manufacturing medical device organization’s quality teams, processes, and procedures that ensure quality controls and disciplines aimed at delivering products that meet customer requirements for safety, quality, and timeliness. Interacts with all levels of leadership within the organization to communicate different quality topics and escalation activities. Serves as the management representative for the site under their purview and for the communication with the different regulatory agencies.
- **What we value**
- Customer First: _We deliver extraordinary experiences._
- Accountability: _We do what we say_
- Integrity: _We do what is right_
- Inspired: _We love what we do_
- One Global Team: _We before me, always_
**What you will do**
- Through a team of quality professionals lead and oversee product quality controls and disciplines that reduce risks and drive product quality in a mass manufacturing environment.
- Serves as the management representative and legal manufacturer representative for the site under their responsibility and when interacting with regulatory agencies.
- Ensures product compliance and regulatory requirements are met through procedures and practices that are aligned with current medical device regulations.
- Accountable for the site’s quality lifecycle, including but not limited to design controls, supplier controls, manufacturing quality controls, corrective and preventive actions, customer complaints, internal and external audits, and regulatory agency visits.
- Supports a multifunctional management and middle-management team in the understanding of regulatory requirements and their industry practices through ensuring processes are controlled and procedures are established and implemented within the framework of an established quality management system.
- Accountable for the training of all site employees in the required quality system and good manufacturing practices training.
- Communicates quality metrics and trends to site and upper management to accurately and timely recognize unfavorable trends or individual situations and escalate actions appropriately.
- Responsible for the effectiveness of the quality management system at their site.
- Through the knowledge of medical device regulation and its industry practice, oversees the day-to-day operations at their site to ensure good manufacturing practices are established, implemented, and maintained.
- Responsible for championing and communicating the organizations’ quality policy and objectives.
- Leads periodic management reviews to drive actions that improve the organization’s practices, processes, and culture of quality improvement.
**What you will need**
**Education**:Bachelor’s degree in Science or Engineering.
- ***Master’s Degree in Science, Engineering, or Business preferred**.**
**Experience**:Minimum 10 years’ experience managing in a world-class manufacturing environment.
- **Language**: Bilingual English / Spanish
- **Other Knowledge, Skills, Abilities or **Certifications**:
- Lean and Six Sigma knowledge as it applies to a manufacturing setting.
- Statistics for Quality Control - use of statistical software such as Minitab.
- Must have requisite training or certification in medical device quality certifications such as ASQ CQE, CQA, RAPS or Six Sigma green or black belt.
- Adept in medical device regulations including but not limited to COFEPRIS, ISO 13485, QSIT, JPAL, MDSAP.
- Strong business communication skills both in English and Spanish.
- Ability to communicate 360 degrees to influence others including executive management personnel.
**What you will like**
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate. Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.
- **Join our team.**
At Corza Medical, we are motivated by enabling our customers’ success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and services that will ensure the continued success of our company and surgical professionals well into the future.
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