drjobs Manufacturing Operations QA Director - Irvine, CA (on-site)

Manufacturing Operations QA Director - Irvine, CA (on-site)

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1 Vacancy
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Job Location drjobs

Toledo - USA

Monthly Salary drjobs

$ 177600 - 266400

Vacancy

1 Vacancy

Job Description

We anticipate the application window for this opening will close on - 15 Jun 2025


At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Join us at Medtronic where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging energizing and rewarding career that changes lives we invite you to join our team. Become part of the next generation of life-changing medical technology impacting patients worldwide.

At Medtronic we must work with a sense of purpose and ownership knowing there is a human life on the other side of every decision.

As the Manufacturing Operations QA Director based in Irvine you will lead our quality site operations specializing in the production of cutting-edge Neurovascular devices designed for stroke aneurysm and embolization treatments. Reporting to the Vice President of Operations Quality for Americas West/Mexico Manufacturing Region you will develop and implement quality management strategies that ensure the highest level of product quality and compliance. This includes harmonizing standards and processes driving synergies and fostering a culture of quality excellence.

Key Responsibilities as the Manufacturing Operations QA Director are:

  • Leadership & Quality Culture:Lead the manufacturing site towards excellence in product quality and operational excellence fostering a culture that prioritizes quality and puts patients first. Champion continuous improvement and quality excellence embedding quality in every aspect of operations.

  • Talent Development:Develop and implement comprehensive training programs to enhance team skills and capabilities. Mentor and coach Managers and Engineers providing opportunities for professional growth and career advancement.

  • Inspection Readiness:Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices. Implement robust quality control processes and regular inspections to ensure compliance with regulatory requirements.

  • Strategic Partnership:Collaborate cross-functionally with colleagues in Global Operations & Supply Chain Strategy & Technology Supplier Quality Micro & Sterilization Assurance Regulatory Affairs R&D and others to drive Quality and Enterprise Operations strategies.

  • Quality Management:Oversee the development and maintenance of quality programs systems processes and procedures that ensure compliance with policies and standards. Provide expertise in interpreting policies and regulations to ensure compliance.

  • Audit Leadership:Lead audit and inspection preparation resolving findings and liaising with auditing groups and inspectors. Facilitate uniform standards worldwide and enable best practice sharing.

  • Continuous Improvement:Create a culture of continuous learning across areas of responsibility identifying root causes of quality issues and institutionalizing organizational learning.

Must Have: Minimum Requirements

To be considered for this role please ensure the minimum requirements and your permanent address are evident on your resume.

  • Bachelors degree required.

  • Minimum of 10 years of relevant Manufacturing Quality / Engineering experience with 7 years of managerial experience or an advanced degree with a minimum of 8 years of relevantManufacturing Quality / Engineeringexperience with 7 years of managerial experience.

Nice to Have

  • Experience in Medical Pharmaceutical or highly regulated product industry.

  • DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.

  • Demonstrated experience leading Kaizen Events and multiple Quality-related functions.

  • Experience with vascular / neurovascular products.

  • Strong leadership change management and transformation skills.

  • Excellent communication interpersonal and talent management skills.

#LI-DNI

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$177600.00 - $266400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan.

The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local law. In addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Required Experience:

Director

Employment Type

Full-Time

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