Quality Engineer II, Manufacturing Operations
Quality Engineer II, Manufacturing Operations
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$ 76800 - 115200
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 seeking a Quality Engineer II who is passionate about ensuring product quality and regulatory compliance in support of innovative medical devices. In this role youll contribute to cross-functional efforts and continuous improvement in a dynamic collaborative environment. In this role you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation process validation inspection improvements and process/quality change initiatives.
This is an onsite role at the Danvers MA location.
As a Quality Engineer II you will:
Support product and process quality for Class II/III medical devices in a regulated manufacturing environment
Lead and support nonconformance investigations CAPA (Corrective and Preventive Actions) and root cause analysis
Perform risk assessments and support risk management documentation (FMEA fault tree analysis)
Provide quality engineering support for design changes process improvements and product launches
Review and approve validations protocols and test methods (IQ/OQ/PQ MSA etc.)
Analyze quality trends monitor metrics and recommend data-driven actions
Collaborate across functions (R&D Manufacturing Regulatory and Supplier Quality) to ensure compliance and product integrity
Support audits and inspections (internal supplier and regulatory bodies)
Contribute to fostering a culture of inclusion safety and continuous learning
Must Have: Minimum Qualifications
Bachelors degree AND minimum of 2 years of relevant experience OR
Advanced degree with 0 years of experience
Nice to Have: Preferred Qualifications
2 years of relevant quality manufacturing or product development experience in a regulated industry (medical device preferred)
Familiarity with FDA regulations (21 CFR Part 820) ISO 13485 and quality systems
Strong analytical problem-solving and effective communication skills
Strong interpersonal and influencing skills
Experience with CAPA risk management tools and statistical analysis
Lean Six Sigma or quality certifications (e.g. ASQ CQE)
Hands-on knowledge of root cause investigation and validation protocols
Experience working in an inclusive cross-functional team setting
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.
Employment Type
Full-Time
