Planet Pharma ยท 16 hours ago
Sr Quality Engineer
Tempe, AZ
Full-time
Onsite
Mid, Senior Level
4+ years expPlanet Pharma is seeking a Senior Quality Engineer responsible for the Quality and Compliance of process development and manufacturing of implantable Cardiac and Neuromodulation medical device products. The role involves leading inspection optimization projects, supporting manufacturing development, and ensuring compliance with quality standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Leading and managing Inspection Optimization projects that span different processes in our microelectronics assembly line. Including both manual visual inspection and automated/semi-automated inspection methods
Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, & OQPQ ensuring compliance and rigor
Partnering with process engineers on development of Test Methods and Test Method Validation plans and execution. Spans both attribute and variables TMVs (Gage R&Rs/MSAs)
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures
Ensure internal quality processes, procedures and systems are compliant to all governing standards
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations
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
Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans and reports
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements
Support CAPA investigations, improvements, and effectiveness verification testing
Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. The Sr Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties
Support and drive proper change control procedures and collaborate with change owners on their implementation strategies and change documentation
Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and projects simultaneously
Communicate clearly regarding technical issues and solutions
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
Qualification
Required
Requires a Baccalaureate Engineering degree and minimum of 4 years of relevant experience OR Master's Engineering degree with a minimum of 2 years relevant experience
Experience with general quality principles, procedures and methodologies
Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation
Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)
Preferred
4+ years of engineering experience in a medical device manufacturing environment
4+ years of Process Quality or Process Engineering experience
DRM or DFSS certification
Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire)
Experience with internal and external audits including FDA, MDSAP and/or TUV
Six Sigma or Lean Sigma belt certification
Strong statistical analysis techniques & DOE design and execution
Strong understanding of medical device manufacturing processes and products
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