Quality Assurance Director jobs in Minnesota

WHO WE ARE:

DDL, Inc. is a third-party testing facility dedicated to helping medical device and pharmaceutical companies across the globe bring products to market. For over 30 years, DDL has provided extraordinary customer service and specialized testing expertise to the medical device, pharmaceutical, and consumer goods industries for our clients’ safety and efficacy testing. We help save lives by providing the highest standards for package, product and material testing.

“Working for DDL the past 8 years, I’ve gained life-long friendships with my co-workers.” – Angela – Packaging Project Manager/Engineer

“There is great daily satisfaction knowing the testing we perform is helping provide safe medical products all around the world.” – Brad – Packaging Project Manager

HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities):

As Director of Quality Assurance, you'll be instrumental in establishing and maintaining a robust quality management system to ensure industry best practices both internally and externally. This position requires extensive knowledge of GMP, GCP, GLP and GDP global regulations along with inspection preparations. The Director of Quality will manage a quality team supporting all DDL site locations.

DDL is a 3rd party testing lab focused on providing testing services to Pharmaceutical and Medical Device customers. This position is a key part for DDL to offer testing services within a cGMP and ISO 17025 regulated business environment.

• Collaborating closely with cross-functional teams, you'll lead continuous improvement. Develop and implement a comprehensive quality assurance strategy aligned with company goals.
• Lead the design, implementation, and maintenance of quality systems, policies, and procedures to support all aspects of testing services.
• Provide strategic direction and oversight for quality assurance activities, including batch release, document control, deviations, investigations, and CAPA management. Lead and mentor a team of quality professionals, fostering a collaborative and high-performance culture.
• Conduct risk assessments and quality reviews to identify areas for improvement.
• Serve as the primary point of contact for inspections, audits, and submissions as necessary.
• Stay updated on industry trends, regulatory updates, and emerging technologies, proactively recommending and implementing changes as needed.
• Work with customers to help navigate industry regulations for submissions.
• Other duties as assigned.

WHAT YOU NEED TO SUCCEED (Minimum Qualifications):

• Bachelor’s degree in Environmental Safety, Occupational Safety and Health. Or Chemist or Biomedical degree with 3 years of EHS experience.
• 15 years of QA experience in the pharmaceutical industry or a combination of pharmaceutical and other related FDA/EU regulated industry.
• 10 years’ experience managing a team.
• 5 years of RA experience.
• Microsoft Office software systems.
• Quality management systems (ZenQMS preferred).
• Prior analytical lab experience.

WHAT WILL SET YOU APART (Competencies):

• Strong mentoring and leadership abilities.
• Extensive knowledge of relevant regulations, such as FDA, EMEA, ICH.
• A depth of FDA facing experience in managing both internal audits and external audits.
• Excellent interpersonal and communication skills and ability to influence diverse cross functional stakeholders and hold accountability.
• Excellent management skills with the ability to drive competency and deliver information at all levels within the organization.
• Excellent communication skills; oral, written, electronic and training/presentation.
• Easily operates and collaborates cross functionally between internal teams/depts.
• Strong self-management and time management skills.
• Team player mindset.
• Ability to adapt and be flexible.
• Other duties as assigned.

WHY JOIN US:

If you’re a team player who is looking for a sense of accomplishment, the opportunity to grow both personally and professionally, and a place to call home, then DDL is the place for you! At DDL, Inc., we strive to offer a competitive salary along with a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Basic Life and AD&D / Voluntary Life and AD&D
• Short-Term Disability
• Long-Term Disability
• Pet Insurance
• Commuter Transit Benefits
• 401(k) Retirement Plan w/Safe Harbor Employer Contribution
• Paid Holidays
• PTO

It is DDL, Inc.’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.