Senior Quality Engineer

4 months ago

Minneapolis, United States ProMed Molded Products Full time

Responsibilities Include:

A key contributor and valued team member of ProMed Pharama, will assist in our strategic plan to grow our customer base, be recognized worldwide by our customers and the regulator agencies as having a top tier quality system from R & D through final production.  Responsible for overall compliance, process and quality assurance activities on numerous projects and products including Pharma products, combination products and medical devices.   Develop and teach systems and templated platforms that assures a complete and auditable quality focus at each step of the process.   

Essential Functions of Job:

  • Ensuring the quality requirements are established implemented and maintained in accordance with the current ISO 13485 (current) Standards, and FDA 21 CFR 820 and 211 regulations.
  • Ensures the Quality Management System activities are developed and deployed in an efficient and effective manner that supports the company's Quality objectives.
  • Directly responsible or oversees approval, and rejection of all procedures and specifications impacting the product.
  • Directly responsible or oversees the supplier qualification process, the audit program (Customer, FDA, Internal), the Document Control process and the investigation process (CAPA, OOS, Deviations, Complaints).
  • Be a key team member on project development teams
· Point out technical and compliance requirements, perform gap assessments and resolve technical issues early on in the product life cycle.
  • Help with supplier audits, regulatory and Customer audits.
· Assist in the startup and scale up of ProMed’s analytical lab including, equipment purchases, SOP development and operator training · Perform method transfers and routine QC testing as required using laboratory equipment such as HPLC, UV/Vis, FTIR and KF.
  • Perform and document root cause investigations, present findings and possible corrective actions for out of specification test results and Non conformances.
  • Perform rudimentary statistical analysis of data and product specifications to evaluate present standards and achieve targeted quality and repeatability.
  • Work with R&D and production engineers to identify and/or resolve material characterization methodology and inspection criteria to fulfil FDA and MDD requirements.
  • Other duties as assigned by QA/R&D/Business management.

Education/Experience:

  • Degree in Chemistry or related field and a minimum of five years’ experience in the field, in the medical device or Pharma fields.
  • Knowledge or background in current testing technologies for FDA regulated products.
  • Understanding or background in lean and six sigma methodologies.
  • Working knowledge of HPLC, UV/Vis, FTIR, KF instrumentation for Lab testing.
  • Experience in regulatory auditing preferred.
  • Working knowledge of Microsoft Excel, Word, Access, and Project.
  • Possess good communication and problem-solving skills.
  • Familiarity with DMAIC problem solving thought process.
  • Proficiency with PCs, and familiarity with word processing, spreadsheets and quality tools.
  • Good statistical analysis capability and working knowledge of Design of Experiments and related software tools.
  • Knowledge/Training to ISO 13485 (current), Medical Devices QM system.
  • Knowledge/Training to ISO 14971 (current), Risk Management.
  • Experience with statistical sampling and sample preparation techniques 21 CFR 210 and 211.
  • Experience with GMP.
  • Team player with ability to be flexible to reprioritize work as needed and wear different hats in a small company environment fulfill ProMed Pharma’s vision and mission.

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