Senior Principal Quality Engineer

Vantive; Oakdale (MN); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) retirement savings plan

Paid time off from 20 to 35 days

Flexible Spending Accounts

Job summary

Vantive is seeking a Senior Principal Quality Engineer in Oakdale, MN, to lead quality support for drug and medical device R&D. The role entails overseeing compliance to international regulations and managing QMS documentation.

The ideal candidate will have over 6 years of experience in the medical device field and expertise in Quality Engineering principles. Vantive offers a competitive salary range of $120,000 to $165,000 annually and comprehensive benefits.

Qualifications

• 6+ years of relevant experience in the medical device or pharmaceutical industry.
• 5+ years of experience in an analytical chemistry or microbiology lab.
• Familiarity with standard laboratory procedures.

Responsibilities

• Lead quality support and sustain activities for drug products and medical devices.
• Ensure compliance with international regulations and local procedures.
• Participate in audit activities and develop audit plans.

Skills

Analytical skills

Problem-solving skills

Communication skills

Familiarity with GLP/GMP

Quality Engineering principles

Education

Bachelor's Degree in a related field

Tools

ISO 13485

EU GMP

Job description

Your Role

The Senior Principal Quality Engineer is responsible for leading quality support and sustaining activities for Drug Products & Medical Device Research & Development activities related to laboratory testing, product validations, and QMS documents management in support of therapeutics products. This role is part of a team of approximately 50 scientists and engineers in Vantive that is building up capability and laboratories in Oakdale, MN, and will be located onsite at least 3 days per week with the team.

What you’ll be doing

• Act as the primary Quality Subject Matter Expert (SME) for drug product and medical devices related activities at the on-site laboratories, working closely with the Quality Manager and the local R&D team to establish local procedures in compliance with international regulations such as EU MDR, as well as the monitoring of local compliance to the Vantive Quality Management System (QMS).
• Review and approve site generated QMS documentation, including but not limited to verification and validation protocols and reports, equipment qualifications, studies, procedures, training plans, change control activities, laboratory investigations, equipment out of tolerance and other quality documentation related to local drug product and medical device R&D activities.
• Support site readiness for and participate in audit activities for the Drugs Products and Sciences R&D groups by developing audit plans, executing internal audits along with Quality Manager, and acting as a Quality SME for external audits, such as those for EU GMP regulation.
• Perform quality-related functions for activities such as Nonconformance Investigation and Corrective and Preventive Action (CAPA) Management.
• Work with other R&D sites to harmonize QMS related laboratory practices and procedures, as well as applicable training.

What you’ll bring

Required Skills

• Bachelor's Degree in a related field and 6+ years of relevant experience in the medical device or pharmaceutical industry or a similarly regulated industry. 5+ years of experience working in and/or supporting an analytical chemistry or microbiology lab in support of regulated products, such drug products.
• Ability and willingness to work independently, communicate effectively, make decisions, and promote compliance to company QMS as a Quality representative for the site.
• Must have familiarity with standard laboratory procedures and requirements under GLP/GMP regulations.
• Demonstrated understanding in general principles of Quality Engineering and worldwide Quality Systemstandards and regulations.

Preferred Skills

• Experience with EU GMP (EudraLex Vol 4.) and ISO 13485 highly preferred
• Experience with ISP and USP Guidelines and Standards highly preferred
• Bachelor’s degree in engineering or a Science discipline
• Formal Audit training or certification
• American Society for Quality Certification (e.g., CQE, CQA, etc.) and/or Six Sigma certification highly preferred
• Experience / understanding of Risk Management techniques and principles
• Ability to work under deadlines and changing priorities with minimal supervision
• Team player with excellent verbal and written communication skills to work cross-functionally in a highly matrixed organizational environment
• Strong analytical and problem-solving skills
• Understanding of scientific method and application of science to test method development and validation highly preferred.
• Ability to multitask, working on multiple projects and work activities running in parallel.

Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $120,000 to $165,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.