Design director [h1.location_city]
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Design director • waterbury ct
[last_updated.last_updated_variable_hours]
Essential Duties & Responsibilities.Effectively utilize quality tools and processes such as product and process controls, risk analysis / management tools, validation, design verification, investigat...[show_more][last_updated.last_updated_variable_days]
RBC Bearings Incorporated (NYSE : RBC / RBCP) is a leading international manufacturer of highly engineered precision bearings, components and essential systems for the industrial, defense and aerospac...[show_more][last_updated.last_updated_30]
SHRM-CP, SPHR, or PHR certification preferred.Stokes Counseling Services is the largest mental health private practice in Connecticut.
Our practice comprises a diverse team of licensed clinicians an...[show_more][last_updated.last_updated_variable_hours]
We are hiring a Human Resources Director to join our dynamic team at Sheriden Woods Health Care Center!.Sheriden Woods is a 146-skilled nursing facility.
Here at Athena Health Care Systems, our empl...[show_more][last_updated.last_updated_variable_days]
We are hiring a Human Resources Director to join our dynamic team at Sheriden Woods Health Care Center!.Sheriden Woods is a 146-skilled nursing facility.
Here at Athena Health Care Systems, our empl...[show_more][last_updated.last_updated_variable_days]
Associate Creative Director (ACD) – Design Cheshire, CT | Full-time | Mid‑Senior level | Design / Art & Creative / Information Technology | Advertising Services We’re Rebels.We create, we provoke,...[show_more][last_updated.last_updated_variable_days]
Medical Director Physician at Enterprise Medical Recruiting summary : .The Medical Director Physician will lead a trauma surgery team in a prominent multispecialty practice, balancing administrative ...[show_more][last_updated.last_updated_30]
RBC Bearings Incorporated (NYSE : RBC / RBCP) is a leading international manufacturer of highly engineered precision bearings, components and essential systems for the industrial, defense and aerospac...[show_more][last_updated.last_updated_variable_days]
Winterberry Irrigation - Full Time.Winterberry Irrigation is looking for a motivated and detail-oriented Design & Estimating Assistant to join our growing team.
This is a fantastic opportunity for s...[show_more][last_updated.last_updated_variable_days]
Direct Hire Director Of Quality.Our client in Prospect, CT is seeking a Direct Hire Director of Quality.At least 10 years of experience in the pharmaceutical and nutraceutical industry in a relevan...[show_more][last_updated.last_updated_30]
We are hiring a Human Resources Director to join our dynamic team at Sheriden Woods Health Care Center!.Sheriden Woods is a 146-skilled nursing facility.
Here at Athena Health Care Systems, our empl...[show_more][last_updated.last_updated_variable_hours]
Associate Director of Primary Care opening in Hartford Connecticut.BC / BE Family or Internal Medicine.Mostly clinical - about 80% Clinical and 20% Admin.
BC / BE Family or Internal Medicine.Monday- Fri...[show_more][last_updated.last_updated_30]
We are seeking a licensed Funeral Director to provide funeral directing services in three Connecticut locations : Woodtick Memorial, Bergin and Lyons Funeral Homes.
You will be part of an existing te...[show_more][last_updated.last_updated_variable_days]
Are you an experienced aviation safety professional seeking an exciting new challenge? Our client is a leading Part 135 commuter and on-demand private charter operator committed to providing top-ti...[show_more][last_updated.last_updated_30]
Direct Hire Director Of Quality.Our client in Prospect, CT is seeking a Direct Hire Director Of Quality.At least 10 years of experience in the pharmaceutical and nutraceutical industry in a relevan...[show_more][last_updated.last_updated_30]
This job supports the matrixed strategic design and analytical approach to reimbursement.To be successful, the incumbent will work closely with stakeholders across the enterprise in the development...[show_more][last_updated.last_updated_30]
Electro-Mechanical Designer – East Windsor, CT area Our client has both New Product Development for new technology products AND of their legacy niche products that the company was founded on sixty ...[show_more][last_updated.last_updated_variable_hours]
At Sikorsky, a Lockheed Martin Company, we are at the forefront of aerospace innovation, driving the development and deployment of cutting-edge technology in the field of aviation.We solve the grea...[show_more][last_updated.last_updated_variable_days]
US-CT-Southington | US-TX-Dallas | US-FL-Boca Raton.The Director of Pharmacy is responsible for supporting the AVP of Medical Cost Containment in the implementation, process improvement, and optimi...[show_more][last_updated.last_updated_variable_days]
- [promoted]
Senior Engineer Design Quality - Consumables
ICU MedicalSouthington, CT, United States[job_card.full_time]
- [promoted]
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Roller Bearing Company of America, IncOxford, CT, US[job_card.full_time]
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Stokes Counseling ServicesNaugatuck, CT, United States[job_card.full_time]
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ParsonshillrehabBristol, CT, United States[job_card.full_time]
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SouthshorerehabcareBristol, CT, United States[job_card.full_time]
Rebellion Group is hiring : ASSOCIATE CREATIVE DIRECTOR (ACD) – DESIGN in Cheshir
Rebellion GroupCheshire, CT, United States[job_card.full_time]
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Enterprise Medical RecruitingNot Specified, CT, USA[job_card.full_time]
- [promoted]
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The Winterberry GroupSouthington, CT, United States[job_card.full_time]
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SoutheastrehabcareBristol, CT, United States[job_card.full_time]
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All Star Healthcare SolutionsNot Specified, CT, USA[job_card.full_time]
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Milestone Funeral PartnerThomaston, CT, US[job_card.full_time]
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Total Aerospace ServicesOxford, CT, US[job_card.full_time]
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PrideStaffProspect, CT, US[job_card.permanent]
Director Reimbursement Design & Market Evaluation
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- [promoted]
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Murphy Search GroupCT, US[job_card.full_time]
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Lockheed MartinConnecticut[job_card.full_time]
- [promoted]
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AmTrust FinancialSouthington, CT, United States[job_card.full_time]
Senior Engineer Design Quality - Consumables
ICU MedicalSouthington, CT, United States[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Expert quality compliance, audit, and investigation skills In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.) Strong knowledge of medical device standards, including but not limited to : ISO 14971 In depth experience with and knowledge of FDA, MDR, and other key medical device regulations Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables Proven ability to work closely with engineering and manufacturing team members Must be at least 18 years of age Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Software) from an accredited college or university is required. Minimum of 7+ years of experience in R&D or Quality is required ASQ CQE or CSQE required or the ability to obtain within one year. This is largely a sedentary role. This job operates in a professional office environment and routinely uses standard office equipment. Typically requires travel 5% to 10% of the time Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. Significant US IV solutions manufacturing and supply capabilities.
Job Description
Essential Duties & Responsibilities
- Effectively utilize quality tools and processes such as product and process controls, risk analysis / management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
- Work with cross-functional teams to coordinate product changes.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Provide corporate quality support, guidance and direction for brining on-market product issues to closure and escalating to senior management for support as necessary.
- Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.
- Ensure compliance, alignment and consistency with ICU Medical's quality system.
- Prepare, support and ensure the readiness for any potential internal and / or external audits and inspections.
- Work special projects as assigned
Knowledge & Skills
ISO 13485
Minimum Qualifications, Education & Experience
Work Environment
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you :
ICU Medical EEO Statement :
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
Know Your Rights : Workplace Discrimination is Illegal Poster
ICU Medical CCPA Notice to Job Applicants