Director of Quality and Continuous Improvement
Director of Quality and Continuous Improvement
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1 Vacancy
Job Description
Eurofins Genomics is a global leader in providing highquality genomics services and solutions for academic clinical and industrial customers. As a trusted partner Eurofins combines high quality product cuttingedge technology and exceptional turnaroundtimes to support customers in wide variety of genomics applications. Join our missiondriven team at our ISO 13485 certified facility and contribute to advancing life sciences through excellence and innovation.
We are seeking an experienced and dynamic Director of Quality and Regulatory Affairs to lead and strengthen our Quality department. The ideal candidate will champion quality and compliance initiatives develop and implement process improvements and ensure adherence to regulatory standards. This role requires a handson leader passionate about driving operational excellence in a fastpaced highly collaborative environment.
Responsibilities:
As the Director of Quality and Regulatory Affairs you will:
- Lead Quality Management Systems (QMS): Maintain and enhance the ISO 13485/ ISO 9001 certified QMS to ensure compliance with applicable standards and regulations including FDA 21 CFR 820.
- Lead Continuous Improvement Initiatives: Apply Lean Six Sigma principles and statistical process control methodologies to streamline operations improve product quality and reduce variability.
- Root Cause Analysis: Investigate nonconformances and implement corrective and preventive actions (CAPAs) to address quality issues and prevent recurrence.
- Regulatory Compliance: Oversee air pollution control reporting hazardous waste registration and related environmental compliance programs.
- Quality Metrics: Develop and monitor key performance indicators (KPIs) to evaluate and improve the effectiveness of quality processes.
- Team Leadership: Build mentor and manage a highperforming Quality team fostering a culture of accountability continuous improvement and collaboration.
- Internal and External Audits: Plan conduct and facilitate successful audits addressing findings promptly and effectively.
- CrossFunctional Collaboration: Work closely with process development production and other departments to align quality objectives with overall company goals.
- Trainings: Manage safety / regulatory trainings for all employees and ensure compliance
- Customer Feedback: Lead all quality related discussions with key customer and ensure high levels of satisfaction
Qualifications :
To excel in this role you should possess:
- Education: Bachelors or higher degree in Engineering Life Sciences or a related field.
- Experience: Minimum of 10 years in Quality Management within a regulated industry with at least 5 years in a leadership role.
- Certifications: Lean Six Sigma certification strongly preferred.
- Technical Skills:
- Expertise in statistical process control (SPC) and root cause analysis.
- Indepth knowledge of ISO 13485 FDA 21 CFR 820 and quality systems regulations.
- Familiarity with air pollution control reporting waste registration and regulatory compliance.
- Leadership Abilities: Proven experience in building and managing effective teams.
- Communication Skills: Excellent verbal and written communication skills for interfacing with internal teams regulatory bodies and customers.
- ProblemSolving Skills: Strong analytical and decisionmaking abilities with a proactive mindset
- HandsOn Approach: Willingness to engage directly with processes and teams to drive improvements.
Additional Information :
Why Join Eurofins Genomics
At Eurofins Genomics we believe that scientific excellence and innovation are only possible through the dedication and expertise of our team. Heres what makes us a great place to work:
- Impact: Contribute to meaningful projects that drive advancements in life sciences and healthcare.
- Innovation: Be part of a culture that embraces cuttingedge technologies and fosters creative problemsolving.
- Collaboration: Work in a dynamic diverse and supportive environment where teamwork is celebrated.
- Career Growth: Benefit from opportunities for professional development and advancement in a global organization.
- Commitment to Quality: Join a company that is deeply committed to excellence integrity and continuous improvement.
If you are a motivated leader with a passion for quality compliance and innovation we invite you to join our team at Eurofins Genomics. Together we will shape the future of genomics and improve lives worldwide.
Apply Now to take the next step in your career journey with Eurofins Genomics!
Position is a full time first shift hourly position.
Will will not consider candidates who require sponsorship to work in the US.
Candidate will be required to sign a noncompete agreement as part of the offer.
What we offer:
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
