Operations Quality Manager Brooklyn Center, MN
Brooklyn Center, MN - USA
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
A career at Medtronic is like no other. Were committed to and driven by our Mission to alleviate pain restore health and extend life for millions of people worldwide!
Join a diverse team of innovators who bring their worldview their unique backgrounds and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
The Operations Quality Manager will lead quality operations for Medtronic Electronics Components Center (MECC) in Brooklyn Center MN a facility that designs develops and manufactures critical components used across multiple Medtronic businesses and therapies. Reporting to the Operations Quality Director this leader will drive quality excellence across the Components Focus Factory including Connectors/Molding Capacitors TDCO and Feedthroughs. The role is responsible for ensuring timely nonconformance disposition and closure partnering with downstream Medtronic sites to investigate and resolve quality issues and fostering a culture of compliance accountability and collaboration. This position will also lead continuous improvement and cost-savings initiatives reduce quality risk support operational performance and develop high-performing teams to ensure the delivery of safe effective and high-quality products that meet customer and regulatory requirements.
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Primary Responsibilities:
Responsibilities may include the following and other duties may be assigned.
Provide 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.
Provide expertise and guidance in interpreting policies regulatory and/or governmental regulations and internal regulations to assure compliance.
Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Lead audit and inspection preparation resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders both internal and external.
Ensure the quality assurance programs and policies are maintained and modified regularly.
Facilitate uniform standards worldwide and enable best practice sharing thereby fostering the achievement of companys mission globally.
Manage and develop engineers supervisors and technician personnel within the Quality function.
Own issues drive solutions and implement improvements to maintain Quality Metrics for the Components Factory at MECC.
Take initiative to establish Lean Philosophy within the team to streamline daily business processes.
Lead quality related problem solving and root cause analysis during manufacturing.
Create a culture of collaboration and proactive quality management within MECC Operations.
Drive standard work to establish One Best Way across focus factories.
Initiate steps to assure the company quality management systems in place are compliant to ISO 13485.
Required Qualifications:
To be considered for this role please ensure the minimum requirements are evident in your applicant profile.
Bachelors Degree in Engineering Science or technical field with 5 years of work experience in Engineering Quality and/or experience in a regulated industry OR Advanced Degree in Engineering Science or technical field with 3 years of work experience in Engineering Quality and/or experience in a regulated industry
Preferred Qualifications:
Experience managing and improving quality systems in compliance with ISO 13485 FDA regulations CAPA nonconformance management change control and document control requirements.
Experience with quality processes within a manufacturing environment including process controls inspection methods validation activities statistical analysis and quality metrics management.
Expertise with CAPA to investigate nonconformances and implement effective corrective actions.
Experience leading internal external customer and regulatory audits; preparing audit responses; addressing findings; and ensuring ongoing compliance with quality and regulatory standards.
Proficiency in applying Lean Six Sigma and continuous improvement tools to reduce quality risk improve process capability drive cost savings establish standard work and improve operational performance.
For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
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.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
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.
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
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
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more