Quality Assurance Engineer (QIAGEN Beverly LLC)

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.

Quality Assurance Engineer (QIAGEN Beverly LLC):

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. Duties include:

1. Identify manufacturing deviations; conduct investigations of manufacturing non-conformances and out-of-specification incidents. Develop, recommend, and implement effective corrective and preventive actions (CAPA);
2. Evaluate and investigate customer complaints, and analyze feedback to identify trends and drive improvements regarding product quality and customer satisfaction;
3. 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;
4. Conduct routine inspections of manufacturing processes and analytical processes, as well as internal audits of records/documents to ensure regulatory and quality compliance;
5. Carry out risk assessments to mitigate potential quality issues. Support the creation and maintenance of risk management plans, including dFMEAs, pFMEAs, and control plans;
6. 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;
7. Perform selection assessment and evaluation of external suppliers. Collaborate with suppliers to address and resolve quality issues (SCAR);
8. Participate during audits conducted by regulatory agencies and/or customers;
9. Train cross-functional teams and junior QA staff, as needed.

May telecommute part of the week from commuting distance to Beverly, MA in accordance with the company's flexible working policy.

Minimum 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.

In an alternative, the employer will accept 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.

Experience must include the following, which may have been gained concurrently:

• 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.

Job site: 100 Cummings Center, Ste. 407J, Beverly, MA 01915. Full-time.

JOB OPPORTUNITY QUALIFIES FOR EMPLOYEE INCENTIVE REFERRAL PROGRAM.

To learn more & to apply online, visit our website at: https://www.qiagen.com/us/careers/jobs/index & reference Job ID US/CA01812.

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

Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve.We inspire with our leadership and make an impact with our actions.We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.

QIAGEN is committed to creating an inclusive environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, disability or any other status protected by applicable law.

QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contactrecruting@qiagen.com. This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.