Senior Quality Engineer
Senior Quality Engineer
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$ 96800 - 145200
1 Vacancy
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
We are currently seeking a dynamic Senior Quality Engineer to join our Advanced Surgical Instruments team in North Haven CT.
This role is critical to day-to-day quality engineering (QE) support within our Advanced Surgical Instruments (ASI) Focus Factory. The ideal candidate will be supporting various products in Advanced Stapling. This role is critical for day-to-day support of the manufacturing of medical devices for clinical use and improvement initiatives to production cells in Advanced Stapling. Also Investigation of critical defects and CAPA implementation will be crucial for success.
As a Senior Quality Engineer you will:
Provide hands-on proactive quality engineering support within a dynamic manufacturing environment.
Support and lead validation activities for existing products and processes in Advanced Stapling.
Support defect investigation through execution of NCMR and/or CAPA
Partner with cross-functional teams to drive continuous improvement and ensure compliance with regulatory and internal standards.
Develop modify apply and maintain quality standards and protocols for materials and products throughout the lifecyclefrom raw materials to finished goods.
Collaborate with engineering and manufacturing teams to maintain and enhance quality systems.
Design and implement inspection methods testing protocols and measurement systems to ensure product integrity and regulatory compliance.
Conduct quality assurance assessments and statistical analyses to identify trends and recommend data-driven corrective and preventive actions.
Participate in cost-reduction initiatives such as Zero Loss Inspection Optimization to support operational efficiency without compromising product quality.
Document and track quality metrics and ensure traceable compliant recordkeeping.
Must Have: Minimum Qualifications
Bachelors Degree with a minimum of 4 years of relevant experience OR
Advanced degree with a minimum of 2 years of relevant experience
Nice to Have: Preferred Qualifications
Knowledge of validation protocols (IQ/OQ/PQ) risk management and root cause analysis tools.
Experience with statistical methods SPC and quality tools such as FMEA CAPA or DOE.
Excellent communication collaboration and problem-solving skills.
Experience in a regulated industry (e.g. medical device pharmaceutical aerospace).
Proficiency in FDA and ISO 13485/9001 quality systems regulations and standards.
Green Belt or Black Belt certification in Six Sigma or similar methodologies.
Experience with data analysis platforms and digital quality systems.
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.
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.
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:
Senior IC
Employment Type
Full-Time
