Planet Pharma · 1 day ago
Sr Design Quality Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is a company focused on quality in the medical device industry. They are seeking a Senior Design Quality Engineer to lead quality improvement projects, ensure regulatory compliance, and collaborate with cross-functional teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
May act as a mentor to colleagues or may direct the work of other lower level professionals
Qualification
Required
Design Assurance/Design Quality
self-driven, independent ability to engage with cross functional teams and manage project workload
5-7 yrs depending on education and experience
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Typically an individual contributor with responsibility in a professional discipline or specialty
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
May act as a mentor to colleagues or may direct the work of other lower level professionals
The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University)
Seasoned individual contributor
Works independently under limited supervision to determine and develop approach to solutions
Coaches and reviews the work of lower level specialists; may manage projects / processes
May be responsible for entire projects or processes within job area
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments
Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties
Makes improvements of processes, systems or products to enhance performance of the job area
Analysis provided is indepth in nature and often provides recommendations on process improvements
Communicates with senior internal and external customers and vendors
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making
May provide guidance, coaching and training to other employees within job area
May manage projects, requiring delegation of work and review of others' work product
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
May have practical knowledge of project management
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Preferred
General quality experience in med device preferred
Lean/six sigma project improvement experience
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase