Job ID: 3144913
Client: A leading player in the Medical Equipment/Devices Industry
Industry: Healthcare Technology
Job Category: Quality Manufacturing
Our esteemed client, a prominent player in the Medical Equipment/Devices sector, is seeking a Quality Engineer II to join their dynamic team. This award-winning client operates globally and is known for pushing the boundaries of healthcare innovation.
Our client is in search of a Quality Engineer II to strengthen their team at a cutting-edge medical device manufacturing site. In this role, you’ll play a vital part in ensuring compliance with industry regulations while collaborating with local, U.S.-based, and international resources. Your responsibilities will include crafting and executing strategic quality plans and regulatory-compliant operational procedures, supporting routine validation, as well as enhancing and expanding projects. If you’re enthusiastic about maintaining high quality standards and desire a fulfilling career, we invite your application.
Roles and Responsibilities:
- Act as a valuable resource for workgroups and project teams, both within and beyond the facility, regarding quality and regulatory matters.
- Stay well-versed in manufacturing processes and products to assess the causes and effects of defects and spot trends in process and product quality.
- Provide technical guidance for projects using methods like pFMEAs, risk reduction, site validations, DOEs, and other assigned experiments and inquiries.
- Ensure that validation protocol content aligns with all applicable quality system requisites and product criteria.
- Lead initiatives and project teams in the application of continuous improvement techniques and methodologies like Six Sigma, 8D, 5-Why, etc.
- Collaborate with designated manufacturing department(s) to maintain the highest quality standards and requirements.
- Initiate, review, and implement policies and procedures concerning product quality and process control as needed.
- Confirm that all activities adhere to government regulations (OSHA, FDA, ISO, etc.) and relevant policies/procedures.
- Organize machine and process capability assessments, scrutinize data, and offer recommendations.
- Facilitate communication among Unit Quality, Unit R&D, and plant personnel regarding new products, enhancements, and product matters.
- Supply test and statistical support for addressing customer complaints and advise on appropriate actions.
- Bachelor’s degree in Engineering, Sciences, Mathematics, or equivalent – Required. Preference for a major in Mechanical Engineering.
- Minimum of Bachelor’s degree AND 3 years of experience in Quality Assurance/Manufacturing OR Master’s degree AND 1 year of experience – Required.
- Strong understanding of statistical/investigative tools such as control limits, SPC, significance studies, P charts, probability studies, 8D, 5-Why, etc. – Required.
- Effective written and verbal communication skills with the capacity to take responsibility and perform tasks independently – Required.
- Familiarity with Validations, IQ, OQ, PQ, and DOEs – Preferred.
- Solid comprehension of QSRs / ISO13485:2016 – Preferred.
- Preferred: Six Sigma training.
- This position may require COVID-19 vaccination or regular testing as per our client’s policy.
- Join us in a culture that promotes inclusivity, growth, and a fulfilling career.
Job ID: 3144913