Director of Quality

2 weeks ago

Circle Pines, United States Resonetics Full time

Overview:

This position employs an individual skilled in advanced quality assurance techniques with an in-depth understanding of ISO 13485 Quality standard and 21 CFR Part 820 Quality System Regulations. Responsible for leading and influencing Resonetics quality inclusive of product quality, new product introduction and quality management system for multiple Resonetics sites. Areas of focus include but are not limited to:

  • Statistical process control including implementation and sharing of best practices
  • Definition and monitoring quality metrics and lead continuous improvement projects
  • Provide customer management for high visibility or multi-site customers
  • Lead the corporate supplier management program
  • Train quality personnel on quality tools and techniques inclusive of GagR&R, SPC, IQ/OQ/PQ Validation Strategy, Root Cause Analysis and Corrective Action, Risk Analysis and pFMEA

This position will focus on improving quality in a contract manufacturing environment. This individual may from time to time directly manage the related activities of specific clients or Resonetics sites as needed.

Additionally, this individual will oversee the maintenance and improvement of the Resonetics ISO certified Quality System and has authority and responsibility to;

  • Ensure the quality system requirements are effectively established and maintained
  • Reporting on the performance of the Quality system to management with executive responsibility
Responsibilities:
  • Oversee the corporate supplier quality management program in alignment with business objectives and regulatory requirements.
  • Collaborate with the Supply Chain department to manage the Approved Supplier List, including procedures for supplier qualification and ongoing evaluation.
  • Oversee supplier performance through the analysis of quality data and implementation of continuous improvement initiatives and supplier corrective actions
  • Work with corporate quality team to establish and maintain the policies necessary to ensure companywide compliance to ISO and government regulations.
  • Lead and train quality personnel in the tools used for problem solving and root cause analysis
  • Responsible for leading QA personnel in support of corporate objectives for oversight of quality and improvement. This includes solicitation of respective department input and participation in process development.
  • Weekly/monthly reporting of activities and chosen performance attributes.
  • Customer liaison for quality related issues. May assume project manager role for specific customer applications.
  • Lead multi-site corrective actions and/or continuous improvement projects
Qualifications:
  • Minimum 7 years experience in a Medical Device Quality Management role.
  • Lean and/or Six Sigma Green Belt or Black Belt
  • Demonstrated background in an ISO 13485 and 21 CFR 820 quality management system.
  • Strong communication skills (verbal and writing)
  • BS degree in a management or engineering discipline
  • Experience hosting FDA inspections and ISO audits

  • Director of Quality

    3 weeks ago

    Circle Pines, United States CareerBuilder Full time

    Overview: This position employs an individual skilled in advanced quality assurance techniques with an in-depth understanding of ISO 13485 Quality standard and 21 CFR Part 820 Quality System Regulations. Responsible for leading and influencing Resonetics quality inclusive of product quality, new product introduction and quality management system for multiple...

  • Lightspeed Engineer

    2 weeks ago

    Circle Pines, Minnesota, United States Resonetics Full time

    Overview: For over 30 years, Resonetics has been a pioneer in micro medical manufacturing. The same passion for innovative laser capabilities that launched Resonetics in 1987 continues to be at the forefront of its medical manufacturing technologies. Resonetics has continued with advanced development of laser processing to solve the most complex...

  • Director of Nursing

    3 weeks ago

    Pembroke Pines, Florida, United States AHC Clarksville LLC Full time

    JOB SUMMARY: The Director of Nursing is to manage the nursing department and administer the nursing programs in compliance with state and federal regulations as well as company policy and procedures. ESSENTIAL JOB DUTIES: To perform this job, an individual must accomplish each essential function satisfactorily, with or without a reasonable accommodation. ...

  • Network Engineer

    2 days ago

    Pembroke Pines, United States City of Hollywood Full time

    Under the general direction of the Director of Information Technology or designee, incumbent performs highly advanced technical and analytical work involving the design, implementation, management and troubleshooting of the City's Local (LAN) and Met Network Engineer, Systems Administrator, Systems, Network Operations, Windows Server, Network

  • Maternal and Fetal Medicine Full-Time position in Pembroke Pines, Florida

    3 weeks ago

    Pembroke Pines, United States Memorial Healthcare System Full time

    The Division of Maternal Fetal Medicine at Memorial Healthcare System is seeking an experienced and highly motivated Fetal Surgeon and Co Director of Fetal Care to join our growing team. Memorial is a quaternary care regional referral center with over 13,000 deliveries annually. The ideal candidate will be board-certified in MFM and have advanced training in...

  • Customer Service Manager

    2 weeks ago

    Social Circle, United States Kenco Full time

    About the Position Directs and coordinates activities of the quality division of the logistics operation to obtain optimum control of quality performance by performing the following duties personally or through subordinate warehouse and traffic clerks: maintaining reporting quality performance, managing quality associates, developing supervisors, warehouse...

  • Maternal and Fetal Medicine Full-Time position in Pembroke Pines, Florida

    2 weeks ago

    Pembroke Pines, Florida, United States Memorial Healthcare System Full time

    The Division of Maternal Fetal Medicine at Memorial Healthcare System is seeking an experienced and highly motivated Fetal Surgeon and Co Director of Fetal Care to join our growing team. Memorial is a quaternary care regional referral center with over 13,000 deliveries annually. The ideal candidate will be board-certified in MFM and have advanced training in...

  • Inventory Control Specialist Supervisor

    3 weeks ago

    Social Circle, United States Masterack Vehicles Full time

    Inventory Control SpecialistDepartment: Masterack OperationsReports to: Director of MaterialsEmployment Status - Full timeJob Summary:The Inventory Control Specialist schedules and coordinates the efficient distribution of material, establishes and maintains inventory accuracy, and aligns Customer Demand and Operation Capacity to fill Orders Ontime and...

  • Inventory Control Specialist Supervisor

    7 days ago

    Social Circle, United States Masterack Vehicles Full time

    Inventory Control SpecialistDepartment: Masterack OperationsReports to: Director of MaterialsEmployment Status - Full timeJob Summary:The Inventory Control Specialist schedules and coordinates the efficient distribution of material, establishes and maintains inventory accuracy, and aligns Customer Demand and Operation Capacity to fill Orders Ontime and...

  • Plastic Surgeon Specializing in Breast Reconstruction Partnership Opportunity

    2 weeks ago

    Southern Pines, United States Pinehurst Surgical Clinic PA Full time

    Job Type Full-timeDescriptionIf the quality of your life matters as much as the quality of your practice, you will want to explore this opportunity. Pinehurst Surgical Clinic is a multi-specialty surgical practice comprised of nine specialty centers located in two main state-of-the-art facilities in Pinehurst and Southern Pines, North Carolina. Moore County...

  • Program Support Assistant

    3 weeks ago

    Bay Pines, United States Veterans Health Administration Full time

    Summary The Program Support Assistant (Credentialing Specialist) is assigned to the Credentialing and Privileging Office, which is under the Chief of Staff at a VA Medical Center (VAMC) and is responsible for providing administrative and technical direction and support to the credentialing operations. The Credentialing Specialist is aligned to and...

  • Navigator

    4 days ago

    Pembroke Pines, United States Memorial Healthcare System Full time

    We have an outstanding reputation for providing patient Learn more below. **Summary**: The Surgical Navigator is a professional member of the health care team who assumes advocacy and accountability for all surgical services patients by collaborating with the referring physicians, Surgeons, Anesthesia providers, Pre admission testing staff, OR and PACU...

  • Health System Specialist

    4 weeks ago

    Bay Pines, United States Department Of Veterans Affairs Full time

    Summary The incumbent is assigned to the Medical Staff Office (Clinical Staff Affairs), which is aligned under the Chief of Staff at a VA Medical Center (VAMC) and is responsible for providing administrative and technical direction and support to the credentialing and privileging (C&P)...

  • Health System Specialist

    4 weeks ago

    Bay Pines, Florida, United States Department Of Veterans Affairs Full time

    Summary The incumbent is assigned to the Medical Staff Office (Clinical Staff Affairs), which is aligned under the Chief of Staff at a VA Medical Center (VAMC) and is responsible for providing administrative and technical direction and support to the credentialing and privileging (C&P) operations. The C&P Specialist is aligned to and supervised by the C&P...

  • Staff Psychologist

    4 weeks ago

    Bay Pines, United States Department Of Veterans Affairs Full time

    Summary *****A recruitment/relocation incentive may be offered to highly qualified candidate(s).***** The Staff Psychologist may be assigned to any location within the BPVAHCS Mental Health & Behavioral Sciences Service (MH&BSS) continuum of care. The incumbent is expected to provide...

  • Staff Psychologist

    3 weeks ago

    Bay Pines, Florida, United States Department Of Veterans Affairs Full time

    Summary *****A recruitment/relocation incentive may be offered to highly qualified candidate(s).*****The Staff Psychologist may be assigned to any location within the BPVAHCS Mental Health & Behavioral Sciences Service (MH&BSS) continuum of care. The incumbent is expected to provide psychological services and consultation with supervisors and peers, as...

  • Inventory Control Specialist Supervisor

    5 days ago

    Social Circle, GA, United States Masterack Vehicles Full time

    Inventory Control Specialist Department: Masterack Operations Reports to: Director of Materials Employment Status - Full time Job Summary: The Inventory Control Specialist schedules and coordinates the efficient distribution of material, establishes and maintains inventory accuracy, and aligns Customer Demand and Operation Capacity to fill Orders Ontime...

  • Master's level Clinician

    4 weeks ago

    Pembroke Pines, United States Ellie Mental Health - 061 Full time

    Ellie Mental Health, South Florida in Pembroke Pines is looking for passionate Master's Level Clinicians  to join our team!   Who is Ellie Mental Health?Ellie Mental Health is a highly successful mental health organization with clinics structured to remove many of the daily obstacles that get in the way of providing world-class mental health services....

  • Master's level Clinician

    4 weeks ago

    Pembroke Pines, United States Ellie Mental Health - 061 Full time

    Job DescriptionJob DescriptionEllie Mental Health, South Florida in Pembroke Pines is looking for passionate Master's Level Clinicians to join our team! Who is Ellie Mental Health?Ellie Mental Health is a highly successful mental health organization with clinics structured to remove many of the daily obstacles that get in the way of providing world-class...

  • Master's level Clinician

    4 weeks ago

    Pembroke Pines, United States Ellie Mental Health Full time

    Job DescriptionJob DescriptionEllie Mental Health, South Florida in Pembroke Pines is looking for passionate Master's level Clinicians to join our team! Who is Ellie Mental Health?Ellie Mental Health is a highly successful mental health organization with clinics structured to remove many of the daily obstacles that get in the way of providing...