Current jobs related to Director of Quality Assurance - Eden Prairie - DDL
-
Director of Quality Assurance
3 days ago
Prairie du Sac, Wisconsin, United States Culver's Full timeCulver's Director of Quality AssuranceCulver's is seeking a highly skilled Director of Quality Assurance to lead the development and implementation of effective quality assurance strategies and practices across all food and beverage products and materials. This role is responsible for providing the highest level of quality assurance services and approaches...
-
Quality Assurance Specialist
4 weeks ago
Eden Prairie, Minnesota, United States Moffat Workforce Full timeQuality Assurance Specialist – Direct HireCompany: Moffat WorkforceWe are seeking a qualified candidate to join our team as a Quality Assurance Specialist. The ideal applicant will possess a minimum of 2 years of experience in quality assurance within the medical device industry, along with a solid grasp of ISO 13485 standards.Key Responsibilities:Execute...
-
Quality Assurance Specialist
5 days ago
Eden Prairie, Minnesota, United States E. A. Sween Company Full timeJob Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at E. A. Sween Company. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.Key Responsibilities:Develop, implement, and maintain company food safety and quality programs to...
-
Quality Assurance Specialist
4 days ago
Eden Prairie, Minnesota, United States Collagen Solutions Full timeJob Title: Quality Assurance SpecialistCollagen Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Develop and implement quality control systems and processes to ensure compliance with...
-
Lead Quality Assurance Engineer
4 weeks ago
Eden Prairie, Minnesota, United States Jobot Full timeOverview: A prominent Tier 1 OEM is in search of a Lead Quality Assurance Engineer to enhance their expanding team.About the Role: As a Lead Quality Assurance Engineer, you will play a pivotal role in steering our quality assurance initiatives, ensuring that our production processes adhere to and surpass the highest quality benchmarks.Key...
-
Quality Assurance Specialist
2 weeks ago
Eden Prairie, Minnesota, United States Aludec Full timeJob SummaryWe are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team at Aludec. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesProvide cosmetic quality guidance to production operators using approved standard cosmetic gauges,...
-
Lead Quality Assurance Engineer
4 weeks ago
Eden Prairie, Minnesota, United States Jobot Full timeTier 1 OEM seeks Lead Quality Assurance Engineer to enhance our quality initiatives. This Jobot Job is hosted by: Ryan Purdy Salary: $100,000 - $130,000 per year About Us: A premier Tier 1 OEM automotive manufacturer with a rich legacy. Why Work With Us? Competitive compensation Positive work environment Comprehensive benefits Growth opportunities ...
-
Lead Quality Assurance Engineer
3 weeks ago
Eden Prairie, Minnesota, United States Jobot Full timeJoin a Leading Tier 1 OEM as a Lead Quality Assurance Engineer.This Jobot Job is hosted by: Ryan PurdyAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $100,000 - $130,000 per yearAbout Us:We are a prominent Tier 1 OEM automotive manufacturer with a legacy of excellence.Why Work With Us?Attractive...
-
Quality Assurance Specialist
4 weeks ago
Eden Prairie, Minnesota, United States Stratasys Full timeQuality Assurance SpecialistLocation: Eden Prairie, MN, USJob ID: 53740Category: Manufacturing & OperationsAbout Stratasys:Stratasys stands at the forefront of 3D printing technology, driving the global transition to additive manufacturing. Our innovative solutions cater to diverse sectors including aerospace, automotive, consumer goods, and healthcare. By...
-
Lead Quality Assurance Engineer
4 weeks ago
Eden Prairie, Minnesota, United States Nuwellis, Inc. Full timeJob OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with various departments including Marketing, Clinical, Regulatory,...
-
Lead Quality Assurance Engineer
4 weeks ago
Eden Prairie, Minnesota, United States Nuwellis, Inc. Full timeJob OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams,...
-
Director, Quality
4 weeks ago
Pleasant Prairie, United States BioSpace, Inc. Full timeJob Details At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Director, Quality
2 months ago
Pleasant Prairie, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Quality Assurance Engineer
4 weeks ago
Eden Prairie, Minnesota, United States Beacon EmbeddedWorks Full timePosition OverviewROLE SUMMARYThe Quality Assurance Engineer is responsible for delivering technical support and manufacturing assistance across all facets of product and process quality. This includes conducting root cause investigations, gathering data, and formulating plans for incoming quality assurance.Reporting Structure: Reports to the Senior Manager...
-
Lead Quality Assurance Engineer
4 weeks ago
Eden Prairie, Minnesota, United States Nuwellis, Inc. Full timeJob OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and...
-
Quality Assurance Specialist
4 days ago
Grand Prairie, Texas, United States First Assured Quality Systems LLC Full timeQuality Control InspectorAre you looking for a challenging career in quality assurance? First Assured Quality Systems LLC is seeking a Quality Control Inspector to join our team.About the RoleWe pride ourselves on being innovative and strive to be industry leaders. As a Quality Control Inspector, you will be responsible for ensuring that products meet...
-
Lead Quality Assurance Engineer
3 weeks ago
Eden Prairie, Minnesota, United States Nuwellis, Inc. Full timeJob OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through innovative therapies.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations. This role is crucial in...
-
Lead Quality Assurance Engineer
3 weeks ago
Eden Prairie, Minnesota, United States Nuwellis, Inc. Full timeJob OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of individuals experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams, taking on...
-
Lead Quality Assurance Engineer
3 weeks ago
Eden Prairie, Minnesota, United States Nuwellis, Inc. Full timeJob OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the lives of patients dealing with fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations....
-
Principal Design Assurance
1 month ago
Eden Prairie, United States Nuwellis, Inc. Full timeJob DescriptionJob DescriptionDescription:Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer partners with Marketing, Clinical, Regulatory, R&D and Operations and has the responsibility to...
Director of Quality Assurance
4 months ago
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 Regulatory Affairs experience.
Microsoft Office software systems.
Quality management systems (ZenQMS preferred).
Prior analytical lab experience.
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.
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
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
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.
#J-18808-Ljbffr
