Quality Director
3 weeks ago
MEDRES INTERNATIONAL INC
Quality Director
Carlsbad, CA·Full time
Company website
Apply for Quality Director
MedRes International is looking for a Quality Director to join our team in our Carlsbad, CA office. The Quality Director will be responsible for deploying a quality system for Design, Development and in-house manufacturing of Class II and III devices at the Carlsbad facility. The Quality Director will lead and perform quality assurance activities in Carlsbad, working under FDA requirements, as a member of the global MedRes Quality team. The position reports to VP, Quality Assurance.
Description
The Quality Director will have experience in developing quality systems, audit, and IQ, OQ, PQ, process validation. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with US & EU Medical Device regulations and other worldwide regulations.
Responsibilities include but not limited to:
· Develop and implement an electronic QMS.
· Support compliance to the following standards: ISO 13485, ISO 14971, FDA registered site.
· Experience with developing and maintaining quality management systems and manufacturing process control.
· Maintain design history file (DHF) and device master records (DMRs).
· Lead and provide direction and objectives for the Carlsbad engineering team ensuring processes within the QMS are maintained and improvements made.
· Ensure internal audits of the Quality Management Systems are carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement.
· Support notified body audits and 3rd party audits and ensure all findings are followed up and closed out in a timely manner.
· Provide progress reports on Departmental KPIs and represent the Quality Department during Senior Management meetings in order to report status and recommend areas for improvement.
· Support new product development ensuring quality plans, specifications, training, and full validations are complete and ensure a smooth transfer to production.
· Manage corrective and preventive actions (CAPAs) and lead CAPA teams as necessary.
· Manage supplier corrective action (SCARs) as necessary.
· Ensure validation of new materials, materials changes, equipment (IQ/OQ/PQ), environment/facilities, through full validation, training, and monitoring.
· Lead Continuous Improvement (CI) projects or assist with Continuous Improvement initiatives and communicate progress to CI teams with regards to key KPIs including waste and customer complaints.
· Manage change control and ensure the document control system is established and maintained.
· Establish supplier quality performance criteria and monitor supplier performance, including assessing supplier’s product specifications and approval of suppliers through site visitation and audit.
· Support the transfer of projects and products between the various MedRes sites.
· Support the development of a global MedRes quality team, including management responsibilities within this team.
Experience & Skills:
· Minimum of a Bachelor’s degree (Master degree desirable), preferably in engineering or technical discipline.
· CQE certification a plus.
· 10+ years’ experience in quality system development and management with progressive and extensive experience in medical device quality assurance.
· Experience with Class II and Class III medical devices.
· Experience with ISO 8 certified cleanroom controlled environments.
· Experience in early-stage startup.
· Experience in all 5 phases of the product development lifecycle.
· Knowledge of project management best practices.
· Experience managing a comprehensive quality group that includes QA, QC, validation.
· Lead Auditor or trained as an internal auditor.
· Lean Six Sigma certification preferred.
· Excellent analytical and statistical skills.
· Excellent communications skills and a track record of accomplishment in leading and mentoring a subordinate team.
Compensation:
The estimated salary range for a new hire in this position is $175,000 to $200,000 depending on background and experience.
#J-18808-Ljbffr
-
Quality Director
5 days ago
Carlsbad, United States MedRes International Full timeMedRes International is looking for a Quality Director to join our team in our Carlsbad, CA office. The Quality Director will be responsible for deploying a quality system for Design, Development and in-house manufacturing of Class II and III devices at the Carlsbad facility. The Quality Director will lead and perform quality assurance activities in...
-
Quality Director
3 weeks ago
Carlsbad, United States Medres Ltd Full timeMedRes International is looking for a Quality Director to join our team in our Carlsbad, CA office. The Quality Director will be responsible for deploying a quality system for Design, Development and in-house manufacturing of Class II and III devices at the Carlsbad facility. The Quality Director will lead and perform quality assurance activities in...
-
Managing Director
2 weeks ago
Carlsbad, United States selescope Full timedu posteReporting to the CEO and member of the management committee, you will be responsible for the company's activities in Germany. In the absence of the CEO, who divides his time between different countries, you will ensure continuity in the management of the site.Your main role will be to guarantee the development of our business and our operational...
-
Director I
1 month ago
Carlsbad, United States Texas Department of Aging & Disability Services Full timeJob Description: Director I - DRS Come work in an environment where we truly value and respect those we serve and believe in the mission that all people can achieve a higher level of wellness and independence. The state supported living centers serve people with intellectual and developmental disabilities who are medically fragile or who have behavioral...
-
Nursing Director- Lvn
3 weeks ago
Carlsbad, United States Sunrise Senior Living Full timeOverview - Additional compensation available with bonus._ The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Director/executive Director of Bioanalytical
2 weeks ago
Carlsbad, United States Ionis Pharmaceuticals, Inc. Full timeIonis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier...
-
Nursing Director- LVN
2 weeks ago
Carlsbad, United States Sunrise Senior Living Full timeOverview Additional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Aquatics Director
1 month ago
Carlsbad, United States Waterworks Aquatics Full timeWe’re hiring for a Full-Time Aquatics Director! A Little About Us…Waterworks Aquatics is a premier swim school that teaches children ages 3 months through adult how to swim. Our mission is to educate and motivate individuals to be safer and learn proper swimming technique. Job Description:Waterworks Aquatics is seeking an ambitious Aquatics Director to...
-
Aquatics Director
1 month ago
Carlsbad, United States Waterworks Aquatics Full timeJob DescriptionJob DescriptionWere hiring for a Full-Time Aquatics Director!A Little About UsWaterworks Aquatics is a premier swim school that teaches children ages 3 months through adult how to swim. Our mission is to educate and motivate individuals to be safer and learn proper swimming technique.Job Description:Waterworks Aquatics is seeking an ambitious...
-
Nursing Director- LVN
1 month ago
Carlsbad, United States Sunrise Senior Living Full timeJOB OVERVIEW Additional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Nursing Director- LVN
1 week ago
Carlsbad, United States Sunrise Senior Living Full timeJob DescriptionOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care...
-
Resident Care Director
2 weeks ago
Carlsbad, United States Sunrise Senior Living Full timeOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Director of Nursing- LVN
1 month ago
Carlsbad, United States Sunrise Senior Living Full timeOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Nursing Director- LVN
2 weeks ago
Carlsbad, United States Sunrise Senior Living Full time: Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 7th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise at La Costa Job ID: (phone number removed) JOB OVERVIEW: Additional compensation available...
-
Nursing Director- LVN
1 month ago
Carlsbad, United States Sunrise Senior Living Full timeOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Nursing Director- LVN
3 weeks ago
Carlsbad, United States Sunrise Senior Living Full timeOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Resident Care Director
5 days ago
Carlsbad, United States Sunrise Senior Living Full timeOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Nursing Director- LVN
3 weeks ago
Carlsbad, United States Sunrise Senior Living Full timeOverviewAdditional compensation available with bonus. The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community. Responsible for oversight and implementation of all Care programs,...
-
Assistant Director of Community Management
2 weeks ago
Carlsbad, United States Associa Full timeThe Assistant Director works directly with the Division Director and is responsible for providing support on administrative operations and supervision of a division, while directly managing a reduced portfolio of community associations. Leadership responsibilities include training, supervising, and evaluating staff and office operations in addition to...
-
Center Director
1 month ago
Carlsbad, United States tapwage Full timeFutures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award, we offer a variety of early education and child care options for families. We pave the way for their lifelong learning journey...
