Quality Assurance Engineer (QIAGEN Beverly LLC)

Qiagen • Beverly, MA

188d • Remote

About The Position

At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We're dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We're always striving to identify talented individuals to join our exceptional teams. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery.

Requirements

• A Master's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related discipline followed by 2 years of post-baccalaureate experience in a validation engineering-related occupation.
• Alternatively, a Bachelor's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related discipline followed by 5 years of post-baccalaureate experience in a validation engineering-related occupation.
• 2 years of quality engineering experience in an ISO or FDA regulated environment, including experience with ISO 13485, ISO 14644-1:2015, cGMP 21CFR 820, and 21CFR Part 11.
• 2 years of experience using asset management software, including Blue Mountain Regulatory Asset Manager and Qualer.
• 2 years of experience using quality management system software, including ZenQMS Master Control, Salesforce, Veeva, and Trackwise.
• 2 years of experience using environmental monitoring software, including Vaisala and SensoScientific.
• 2 years of experience conducting data analysis to identify trends, risks, and areas for improvement as well as to prepare and present reports to senior executive leadership.
• 2 years of experience using production management software, including Tracelink and SAP.
• 2 years of experience with ISO 14971: 2019 to implement risk management strategies to mitigate product quality or compliance risks.
• 2 years of experience with root cause analysis and permanent corrective action techniques, including 5Whys, Fishborne Diagram, 6M, and 8D.
• 2 years of experience conducting internal audits and assisting with onsite client external audits.

Responsibilities

• Collaborate with product development teams to ensure the designs, procedures, and outcomes of the project are acceptable in quality.
• Monitor engineering change controls and provide corrective action solutions that drive continuous development.
• Identify manufacturing deviations; conduct investigations of manufacturing non-conformances and out-of-specification incidents.
• Develop, recommend, and implement effective corrective and preventive actions (CAPA).
• Evaluate and investigate customer complaints, and analyze feedback to identify trends and drive improvements regarding product quality and customer satisfaction.
• Review and approve quality documentation, such as standard operating procedures (SOPs), product specification and release documents, batch records, analytical records/reports, and equipment qualification/validation reports.
• Conduct routine inspections of manufacturing processes and analytical processes, as well as internal audits of records/documents to ensure regulatory and quality compliance.
• Carry out risk assessments to mitigate potential quality issues.
• Support the creation and maintenance of risk management plans, including dFMEAs, pFMEAs, and control plans.
• Identify and establish quality-related monthly and quarterly metrics in collaboration with department leads; prepare reports by collecting, analyzing, and summarizing data for presentation to senior leaders.
• Apply statistical techniques to analyze data, and determine and implement improvements towards meeting those goals.
• Perform selection assessment and evaluation of external suppliers.
• Collaborate with suppliers to address and resolve quality issues (SCAR).
• Participate during audits conducted by regulatory agencies and/or customers.
• Train cross-functional teams and junior QA staff, as needed.

Benefits

• Bonus/Commission
• Local benefits
• Referral Program
• Volunteer Day
• Internal Academy (QIALearn)
• Employee Assistance Program and internal QIAGEN communities
• Hybrid work (conditional to your role)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Master's degree