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Quality Engineer

Minnetonka, MN 55343

Posted: 10/10/2023 Employment Type: Contract Job Category: Engineering Job Number: 584619 Is job remote?: No Country: United States

Job Description

Description:

As the Quality Engineer-Contract, you will lead quality engineering activities for commercial and development combination products. You will also participate in quality engineering activities for commercial scale up prior to product launch and support contract manufacturing.   Pay rate range: $60-68/hr
In this role, you’ll have the opportunity to:
•    Evaluate mechanical product design and identify potential design quality issues and drive technical decisions. 
•    Lead and support DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps.
•    Lead CAPA/NCR/SCAR/complaint investigations and reports
•    Supports and ensures the establishment of objective and measurable product requirements.
•    Support engineering print specification definitions, development, and changes
•    Lead preparation and maintenance of risk management files from product conception through post market surveillance 
•    Develop and maintain product release testing plans, associated test methods and procedures.
•    Support design test and inspection method development and validation
•    Support design verification/validation and reliability study execution
•    Support contract manufacturing activities including Process Development, Process Validation (IQ/OQ/PQ), and Nonconformance Resolution 
•    Identifies and leads continuous improvement projects and quality systems improvements.

To succeed in this role, you’ll need:
•    BS degree in an engineering or physical/life science field with a minimum of 5 years relevant experience within the medical device industry or related function (a combination of education and experience may be considered) 

•    Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
•    Good statistical data analysis skills
•    Background in manufacturing processes for drug-device combination products related to development and commercial programs. 
•    Excellent verbal and written communication skills
•    Ability to collaborate with internal customers, 3rd-party partners, and CMOs.
In return, we offer you:
•    Hybrid work flexibility
•    A collaborative, innovative team that works as one to amplify your impact on your career, the work you do and patients’ lives.

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Minnetonka, MN

Discover exciting job opportunities in the enchanting Minnetonka, Minnesota area! Embrace a thriving professional scene amidst the picturesque landscapes and vibrant culture this region has to offer. From the iconic Minnehaha Falls to the renowned Guthrie Theater, there's no shortage of attractions to explore during your off hours. Indulge in the local delicacies like Juicy Lucy burgers and explore the numerous art galleries and parks that make this area truly unique. Whether you're a sports enthusiast cheering for the Vikings at U.S. Bank Stadium or seeking tranquility in the stunning Lake Minnetonka, this region promises growth opportunities and a fulfilling career path. Start your journey today by exploring our latest job listings in Minnetonka, MN!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.