Principal Quality Engineer

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); Sur place; USD 121 000 - 205 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental and vision insurance

401(k) with company match

Paid time off and holidays

Résumé du poste

MiniMed invites qualified professionals to join our team as Principal Quality Engineer. The role focuses on CAPA programs with rigorous investigation, corrective and preventive actions, and ensuring quality systems meet internal and external standards.

You will work with quality, engineering, and manufacturing to uphold high reliability and regulatory compliance. The position requires onsite work at CA sites (Northridge or San Diego) and offers a comprehensive benefits package, competitive

Qualifications

• Bachelor's degree or advanced degree with 5+ years in medical device/pharma
• 3+ years CAPA experience
• Experience collaborating with quality, engineering and manufacturing teams

Responsabilités

• Lead CAPA investigations and determine corrective/preventive actions
• Oversee development and maintenance of quality programs and procedures
• Collaborate with quality, engineering and manufacturing to ensure robust root-cause analysis
• Ensure corrective actions meet reliability standards and are well documented
• Prepare reports for internal and external stakeholders
• Maintain and update QA programs and policies as needed
• Specialize in design, production control, product evaluation or R&D as applied to quality

Connaissances

CAPA experience

Root-cause investigation

Quality engineering

Regulatory audits experience

Formation

Bachelor's degree

Advanced degree

Outils

Trackwise

Description du poste

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

• The Principal Quality Engineer will support CAPA programs particularly focused on robust investigation as well as determination and implementation of corrective and preventative actions.
• 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.
• Collaborates with quality, engineering and manufacturing functions to ensure quality standards are in place and supports rigorous cross-functional root-cause investigation.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Prepares reports and/or necessary documentation provided to applicable stakeholders, both internal and external.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• May specialize in the areas of design, production control, product evaluation and reliability, and/or research and development as they apply to product or process quality.

This role requires you to work 3 days on-site at one of these US sites: Northridge or San Diego, CA.

Must Have: Minimum Requirements

Bachelor's degree and 7+ years of medical device or pharmaceutical industry related experience or Advanced degree and 5+ years of medical device or pharmaceutical industry related experience. 3+ years CAPA experience.

Nice To Have:

• CAPA and root cause investigation experience
• Trackwise software experience
• Experience supporting regulatory audits
• Quality engineering background for medical devices

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

MiniMed offers a competitive salary and flexible benefits package. At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$109,000.00 - $185,000.00. For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000 - $205,000 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). This position is eligible for a short-term incentive called the Short Term Incentive (STI). At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualifi