Director, Quality

Integer Holdings Corporation; Tijuana; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Integer Holdings Corporation seeks a senior Quality leader to drive site quality across manufacturing operations. You will ensure regulatory compliance, elevate the local QMS within the Integer QMS, and lead initiatives to strengthen customer experience and product quality.

You’ll build a high-performing team, manage defects and CAPAs, and partner with engineering for robust design transfer. Required: 10+ years in regulated manufacturing with 6+ years in management, ASQ/ Six Sigma credentials,

Formación

• Bachelor's degree in quality engineering or related field; Master's preferred.
• ASQ Quality Manager/Engineer or Six Sigma Black Belt preferred.
• 10+ years of experience, including 6+ years in management in a Medical Device or other regulated manufacturing environment.
• Expertise in 21CFR820, ISO13485, ISO9001, EU MDR, GMPs, auditing, design controls and statistical concepts (DOE, Capability Studies, Validations).
• Strong problem-solving and communication; high emotional intelligence; limited travel (<25%).

Responsabilidades

• Provide energetic and strategic quality leadership to the manufacturing site(s) assigned.
• Ensure sites meet customer requirements while maintaining compliance with quality and regulatory standards.
• Elevate the local QMS within the Integer QMS and lead quality initiatives.
• Drive change management to design quality into product and process through robust characterization and capability activity.
• Serve as the management representative for the full local QMS and build a high-performing team.
• Liaise for customer quality escalations and review key quality records (CAPAs, NCRs, change notices).
• Develop talent through onboarding, development planning, and succession planning.

Conocimientos

Quality leadership

Regulatory compliance

Customer focus

Change management

Educación

Bachelor's degree in quality engineering or related field

Master's degree preferred

Herramientas

ASQ Quality Manager/Engineer

Six Sigma Black Belt

Descripción del empleo

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

• Customer We focus on our customers’ success
• Innovation We create better solutions
• Collaboration We create success together
• Inclusion We always interact with others respectfully
• Candor We are open and honest with one another
• Integrity We do the right things and do things right

Who are we?

Integer is a global provider of innovative technologies and manufacturing solutions to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide.

We are guided by our Values Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity.

What you’ll do in this role:

Provide energetic and strategic quality leadership to the manufacturing site(s) assigned to: Ensure sites meet customer requirements while maintaining. Compliance with applicable quality and regulatory standards, policies and procedures; and adhere to Integer Values and all safety, environmental, security requirements and regulations. Elevate the impact of the local QMS within the overarching Integer QMS. Lead the execution of quality initiatives to promote and reinforce a culture of quality, customer experience, and innovation. Influence and drive change management to design quality into product and process through robust characterization and capability activity, to increase the velocity of improvement. Serve as the management representative accountable for the full local QMS. Build and lead a high-performing Quality team, fostering company pride. Develop a proactive site approach to the customer experience fostering trust, while also serving as a principal liaison for customer quality escalations. Review and approve key quality records including but not limited to engineering change requests, customer change notices, nonconformance reports, engineering reports, CAPAs, etc. You are accountable for correcting and preventing quality related gaps in existing processes and driving process improvements required to enable the organization to execute at a more accurate and efficient level. Build & develop teams: Create and sustain an environment for developing talent from initial onboarding, through individual development planning, and organizational succession planning. Model the way by coaching team members. Advocate effectively for your team, proactively build the team “brand” and embed an ‘I own Quality’ mindset. Establish clear objectives, communication rhythms, and an empowered collaborative, inclusive, and accountable culture based on mutual trust. Customer Experience and Innovation: Serve as the primary quality customer interface, ensuring transparent, timely and responsive communication. Improve customer-facing metrics (e.g. Complaint metrics) and prevent recurrence through effective CAPA. Champion built-in quality, experiment-and-learn approaches, and data-driven improvements that accelerate safe, reliable new product introductions and product/process changes. Encourage, leverage and adopt technology to improve speed, control and visibility in the quality system. Design Assurance, NPI and Design Transfer: Provide design assurance leadership for new products, line extensions, and other customer driven product development. Enable a “quality by design” mindset; comply with company’s Product Development Process. Partner with R&D and Advanced Manufacturing Engineering to ensure robust design transfer with acceptable process capability and 1st pass yields for production. Manufacturing Support: Align with Plant leadership on prioritized projects, ensuring completion and proactive quality support. Ensure plant operates with robust controls for nonconformance and supplier quality processes, including but not limited to containment, bounding, root cause analysis, corrective/preventive actions, and effectiveness checks. When needed, lead cross site quality resolution. Partner with Engineering to support tooling, equipment and process improvements. Support simplification and lean (5S) principles across the sites. Manage budget and strategic plans. When appropriate, develop business case justifications for additional resources and investment. Provide support of Integer’s Strategic Imperatives: Embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas: Strategy Alignment through quality planning meetings, as Quality representative at site Plant Leadership team meetings, and through site all-hands communication meetings. Leadership of Sustained Change by identifying opportunities to continuously improve our processes and products in compliance with all customer contractual obligations and regulatory requirements. Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, robust training & certification programs and the adoption of Quality policies and procedures that are aligned to and harmonized with the enterprise (Integer) Quality Management System. Associate Engagement at all levels of the organization, promoted through collaborative problem solving, behavior-based safety programs, and improvement idea and systems. Systems & Process Optimization through adoption of principles of built-in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance.

How you will be measured:

Success will be measured through site participation in Integer Environmental, Health & Safety; achievement of goals and objectives including quality and delivery metrics, continuous improvement contributions, and associate engagement and development.

What sets you apart:

Minimum education: Bachelor’s degree in a quality engineering or related field; Master’s degree preferred. Certifications such as ASQ Quality Manager/Engineer or Six Sigma Black Belt preferred.

Minimum experience: .10+ years of experience, including 6+ years in management in a Medical Device or other regulated manufacturing environment. Specialized knowledge and skills Expertise in 21CFR820, ISO13485, ISO9001, EU MDR, Good Manufacturing Practices, auditing, design controls and statistical concepts including Design of Experiments, Capability Studies, Validations, etc. Strong critical thinking and problem-solving skills with excellent written and verbal communication skills. High degree of Emotional Intelligence and can share examples of developing talent. Limited travel (less than 25%). Must have a current passport and are able to secure appropriate visas, as required, for travel to international locations.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®.

Additional information is available at www.integer.net.

Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.

Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as “Protected Veterans.” It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.

Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at [phone] or via [e-mail] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email.

For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login.

For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.

Thanks for your interest in working on our team!!