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Senior Quality Engineer
3 months ago
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.
The Sr. Quality Engineer works under minimal supervision to provide quality assurance support in accordance with regulatory requirements as it relates to biologic therapeutics and compliance with cGMP, relevant ICH and Global regulations. This role will support the execution of medium complexity projects that will impact the Quality of the product.
Responsibilities:
- Primary focus on supplier management to include supplier qualification, audits, SCARs, authoring Quality/Technical Agreements and on-going supplier monitoring.
- Perform and support internal and external audits.
- Interface and collaborate with internal departments and external regulatory bodies regarding compliance needs as required.
- May review and approve Complaint, CAPA, Audit Findings, Deviation investigations to provide guidance to ensure effective investigations are completed.
- Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
- Participate in third party (Notified Body, FDA,) audits as required.
- May work with high-risk investigation to document Quality Issues resolutions within a CAPA, SCAR, Deviation, Audit finding to ensure proper and robust actions are taken to eliminate re-occurrence.
- May guide, coach, and train other personnel on topics such as auditing, Root Cause Analysis, CAPA, deviations, etc.
- Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
- Ensure Site Metrics are complying with internal requirements and goals established.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- May manage or support implementation of electronic QMS
- Contributes to continuous process improvement efforts, improve efficiency, quality culture reinforcement, and eliminate waste.
- Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Performs other duties as assigned based on business needs.
Requirements:
- Bachelor's degree in science or engineering discipline
- Minimum 6 years' experience to include: Minimum 4 years supplier quality
- Minimum 3 years' experience in FDA regulated medical device or pharmaceutical industry.
- Demonstrated experience in problem solving and root cause analysis methods.
- Demonstrated experience in process risk management methods.
- High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel and ERP/MRP systems.
- Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.
- Certified auditor preferred.
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $130,000 to $145,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, 40 hours of sick time, vacation time for full time employees to accrue up to 150 hours in the first four (4) years of employment, and hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.
Location:Roseville, Minnesota
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled