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Senior Quality Assurance Engineer - Beverly, United States - QIAGEN
Description
Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
Position Description
Job performance will involve a variety of activities including:
Directly supports QA exception system including CAPAs, deviations, NCMRs, customer complaints and recalls. Ensures timely response, performs root cause analysis and participates in continual improvement process.
Coordinates and/or performs Internal Audits to ensure ISO 13485 and internal QS compliance.
Participates in product and process cross-functional teams and ensures ISO 13485 and internal QS compliance.
Proven communication skills and ability to work within cross-functional teams to instill a culture of regulatory compliance and continual improvement.
Participates in risk assessment and management of new products and processes.
Coordinates and supports on-site audits conducted by regulatory agencies and/or customers.
Supports and performs external supplier audits to ensure ISO and internal QMS compliance.
Participates in bi-annual documentation review for continued accuracy and training requirements.
Additional responsibilities may be assigned as needed.
Position Requirements
At least 5-7 years of experience in an ISO and/or FDA regulated environment, with at least 4 years in a direct Quality Engineer role.
Bachelor's degree from four-year College or university preferably in a life science discipline, or equivalent experience.
ASQ CQE, CQM, or CQA preferred.
Experience with ISO 13485 certification, (FDA 21CFR 820 and 21CFR Part 11 also desired).
Experience with Risk Management per ISO 14971:2019 desired.
Experience in a Good Manufacturing Practice (GMP) environment.
ASQ certified Quality Auditor and/or Quality Engineer - CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable.
Personal Requirements
Drive and Determination
Strong Molecular Biology background
Positive external and internal relationship management skills
Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
Strong communication and presentation skills
Proven Ability to thrive in a start-up /change oriented environment
Proven coaching, mentoring, team-building and leadership skills
Self Starter
Driven to perform
Self-directed: needs little explicit direction and no hand-holding
Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.
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