Sr. Mfg. Operations QA Manager
Sr. Mfg. Operations QA Manager
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Job Description
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
This Position is the Quality Site Leader role for a Manufacturing site for Class III complex electro-mechanical medical devices. The role is also the Management Representative for the QMS entity and will be interacting with multiple stakeholders within GOSC OUs and Enterprise functions. It is an excellent opportunity for Seniors Managers ready to move to the next step and with the experience and competences to lead the quality team and manage Operations Quality and QMS activities at a medium size/complex site. Role will be directly responsible for Compliance/QMS Incoming Inspection Quality Engineering and Inspection New Products Quality Assurance and a Metallurgy Laboratory and indirectly for Microbiology/Sterility Assurance and Supplier Quality. The role will also support other sites in the Caribbean Region offering Incoming and Laboratory Services.The role will report to the Caribbean Region Operations Quality leader.
Responsibilities may include the following and other duties may be assigned.
- Leads a manufacturing site to excellence in product quality operational excellence and a culture of putting patients first.
- Drives the combined Quality and GOSC strategies to deliver results.
- Interacts with and influences leaders across multiple leadership teams (Core Quality OUs and GOSC).
- Provides oversight for the development and maintenance of quality programs systems processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and 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.
- Facilitates uniform standards worldwide and enables best practice sharing thereby fostering the achievement of companys mission globally.
- May develop evaluate implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials techniques or company products.
- Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
Must Have: Minimum Requirements
- Requires broad management knowledge to lead project teams in one department.
- Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
- Requires a Bachelor Degree
- and minimum of 7 years of relevant experience with 5 years of managerial experience or advanced degree with a minimum of 5 years of relevant experience with 5 years of managerial experience.
Nice to Have-
- Experience with electro-mechanical medical devices and infusion pumps
- Experience with Class III Medical Devices Manufacturing Pre-market and Post-market quality activities
- Experience leading external audits mainly working with the FDA as Front Room leader or Management Representative
- Problem Solving and technical leadership Six Sigma Green or Black belt certified knowledge in FTQ DRM etc.
- Strong leadership competencies for communicating and influencing Senior leaders across the matrix and in different functions (Manufacturing Operations Supply Chain Supplier Quality R&D Design Quality Regulatory OI CQS etc.).
- Knowledge and Skills in Quality Risk Management
- Experience managing laboratories and working with internal suppliers and customers.
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.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
Employment Type
Full-Time
