Senior Director, Quality

2 weeks ago

California, United States Hologic Full time

The Senior Director, Quality manages the development, implementation, and maintenance of Quality System processes. This position will interface with cross-functional departments facilitating resolution of events in compliance with divisional and corporate requirements. As a leader, the candidate is expected to effectively lead and mentor. Essential Duties and Responsibilities •Manages processes and teams associated with control of nonconforming products, CAPAs, deviations, complaints management, complaint investigations, post-market surveillance, audits, quality system, document control, incoming inspections, product release, and other Quality Assurance related processes and teams. •Ensures the risk management program is state-of-the-art. •In partnership with the VP of Quality, establishes overall short and long-term quality strategy and objectives. •Prepares operating and capital budgets which include resource requirements. •Interfaces with other departments and partners to ensure implementation of good compliance practices. •Interacts and leads teams made up of other site leaders to improve the Agile system and shared processes. •Initiates and manages projects to continuously improve and increase efficiency of quality processes. •Prepares for and leads third party regulatory and supplier audits and inspections. •Establishes, monitors, and reports key process indicators and drive actions as needed. •Manages data analytics associated with collected/compiled data. •Develops and manages trending programs. •Establishes and manages training programs focused on cGMP, QMS, defect awareness, Quality at the Source, and other training programs that promote quality awareness and understanding. •Ensures compliance to site, corporate, and regulatory requirements as defined by applicable regulatory bodies and agencies. •Monitors development of new or updates to existing regulations and accurately and effectively translates them into workable processes and procedures. •Promotes awareness of regulatory and customer requirements. •Promotes the Culture of Quality throughout the organization. •Works across sites to harmonize and/or align processes. •Supports the ongoing development and implementation of a Corporate Quality System. •Creates reports for and manages meetings covering Management Reviews. •Manages projects and/or cross functional teams as needed. •Creates bench-marking opportunities to seek best practices with the intention to improve internal processes. •Motivates and manages teams for high engagement and performance. •Develops and manages budget. •Other duties as assigned. Qualifications Education: •Bachelor degree required in life sciences, physical sciences, engineering or applicable technical field. •ASQ Certification or equivalent experience desired Experience: •A minimum of 8-10 years in Quality Assurance/Regulatory Compliance management for the design, production, and on-market support of medical or IVD products •Proven track record in leading multiple teams effectively •Successful experience managing senior and mid-level leaders Skills/Knowledge: •Strong understanding of applicable regulations, such as but not limited to, the Medical Device Regulations, IVD Regulation, QSR, ISO 13485, ISO 14971, MDSAP, MDDAP, etc. •Knowledge of Operational Excellence and Shingo Model desired •Strong aptitude for troubleshooting mechanical and assay specific events partnering with others through resolution. •Extremely intuitive with problem solving and resolutions utilizing risk management tools. •Excellent attention to detail and ability to multi-task. •Proven people manager and able to work with minimum supervision. •Excellent verbal and written communication skills. •Must be able to develop, lead, and motivate a team within a fast-paced manufacturing and design setting. The annualized base salary range for this role is $174,000 to $249,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V) Hologic is hiring a 2ndshift Technician at our Londonderry, NH facility supporting our medical device manufacturing. This is a direct hire position during the hours of 3:00pm- 11:30pm Monday-Friday with OT available ... The Senior Financial Auditor is a member of the Internal Audit (IA) team who is responsible for executing assigned financial, operational, and compliance engagements. This responsibility includes developing the audit ... , US, CO

Employee As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day. Hologic's Bolder Surgical ("Bolder") facility in Louisville, CO, is seeking a Product ... Surgical Territory Manager - Green Bay, WI

Green Bay, WI, United States, US, MA

Employee As the Territory Manager (TM) here at Hologic, you will lead the way to achieve year on year growth within your territory for our GYN Surgical portfolio inclusive ofNovaSure™ global endometrial ablation and MyoSure™ ...

#J-18808-Ljbffr

  • Senior Director, Quality

    2 weeks ago

    California, United States CareerBuilder Full time

    The Senior Director, Quality manages the development, implementation, and maintenance of Quality System processes. This position will interface with cross-functional departments facilitating resolution of events in compliance with divisional and corporate requirements. As a leader, the candidate is expected to effectively lead and mentor. Essential Duties...

  • Director of Sales

    Found in: Resume Library US A2 - 2 weeks ago

    Carmichael, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Carmichael Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that...

  • Director of Sales

    Found in: Resume Library US A2 - 2 weeks ago

    Danville, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Danville Job ID: (phone number removed) JOB OVERVIEW: Compensation listed is base...

  • Director of Sales

    Found in: Resume Library US A2 - 2 weeks ago

    Sunnyvale, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Sunnyvale Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that...

  • Activity Director

    Found in: Resume Library US A2 - 2 weeks ago

    Mission Viejo, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Mission Viejo Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place...

  • Director of Sales

    Found in: Resume Library US A2 - 2 days ago

    Fair Oaks, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Fair Oaks Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that...

  • Director of Sales

    Found in: Resume Library US A2 - 3 weeks ago

    Hermosa Beach, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Hermosa Beach Job ID: (phone number removed) JOB OVERVIEW: Rate listed is base only. ...

  • Director of Sales

    Found in: Resume Library US A2 - 2 weeks ago

    Mission Viejo, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Mission Viejo Job ID: (phone number removed) JOB OVERVIEW: Compensation listed is base...

  • Director of Quality

    Found in: Resume Library US A2 - 2 weeks ago

    Clovis, California, United States Stardom Employment Consultants Full time

    Overview:We are seeking an experienced and visionary Director of Quality to lead our organization's quality assurance and quality control efforts. The Director of Quality will be responsible for developing and executing a comprehensive quality strategy, driving continuous improvement initiatives, and ensuring adherence to regulatory requirements and industry...

  • Director of Quality

    Found in: Resume Library US A2 - 2 weeks ago

    Fresno, California, United States Stardom Employment Consultants Full time

    Overview:We are seeking an experienced and visionary Director of Quality to lead our organization's quality assurance and quality control efforts. The Director of Quality will be responsible for developing and executing a comprehensive quality strategy, driving continuous improvement initiatives, and ensuring adherence to regulatory requirements and industry...

  • Associate Director

    1 week ago

    California, United States Parent Institute for Quality Education Full time

    All Jobs  >  Associate Director - SFEC - Central Valley Associate Director - SFEC - Central Valley Central Valley, CA Description ****Candidates Must Reside in the State of California to be considered**** Since 1987, PIQE has dedicated it's work to achieving economic and social equity for all through education. By listening to families and developing...

  • Medical Director/Senior Medical Director

    Found in: Jooble US O C2 - 3 weeks ago

    California, United States GQR Full time

    The Director/Senior Medical Director, reporting to the Chief Medical Officer, plays a pivotal role in steering clinical development initiatives. With a focus on ensuring adherence to GCP, SOPs, and regulatory standards, this role orchestrates the planning and execution of clinical studies, driving programs through the research process efficiently. Key...

  • Quality Assurance Director

    Found in: Resume Library US A2 - 2 weeks ago

    Fresno, California, United States Stardom Employment Consultants Full time

    QA Director Job Description As a QA Director, you will play a pivotal role in ensuring the quality and reliability of our products and services. You'll lead the quality assurance function, collaborating with cross-functional teams to establish and maintain high standards. Your expertise will drive continuous improvement, risk management, and compliance...

  • Director, Finance

    1 week ago

    California, United States Queensland Treasury Full time

    Purpose of Role As the Director, Finance (Senior Manager Group Finance), your primary responsibility will be to provide overall leadership of the Group Finance team including delivering the annual financial statements and audit. You will ensure effective financial management of QTC’s accounting processes and key internal controls, with a focus to...

  • Program Delivery Quality Director

    Found in: Resume Library US A2 - 2 weeks ago

    Sacramento, California, United States AECOM Full time

    Job Description AECOM is seeking a Program Delivery Quality Director​ to be based in Sacramento, CA. JOB SUMMARY: The Program Delivery Quality Director provides leadership, develops, implements, and maintain the HSR Quality Management Systems.  JOB RESPONSIBILITIES: ​​ ​​ Leadership for all Quality related initiatives in support of the...

  • Assisted Living Coordinator

    Found in: Resume Library US A2 - 7 days ago

    Rocklin, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Rocklin Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that...

  • Director/Senior Director, Regulatory Affairs

    1 week ago

    California, United States Avita Medical Full time

    Director/Senior Director, Regulatory Affairs – Irvine or Valencia Position summary: Plans, executes, and oversees daily activities associated with Global Regulatory Affairs. Primary responsibilities include guidance and mentoring of Regulatory staff and acting as Regulatory leader in the Medical, Legal and Regulatory Review process including review,...

  • Senior Quality Specialist

    Found in: Resume Library US A2 - 3 weeks ago

    Selma, California, United States Flatiron Construction Corp Full time

    Overview: Flatiron is a leading provider of infrastructure construction that develops innovative solutions to construct some of the most complex and noteworthy infrastructure projects in the U.S. and Canada. We are looking to hire a Senior Quality Specialist to join the CA High Speed Rail project in Northern CA. As a Senior Quality Specialist you will...

  • Director, Quality and Continuous Improvement Canada

    Found in: Resume Library US A2 - 1 week ago

    Ontario, California, United States Cornerstone Building Brands Full time

    Job Description The Director of Quality and Continuous Improvement Canada will provide leadership, direction, and oversight of quality assurance and continuous improvement efforts for improved customer satisfaction and operational efficiency. This leader will report directly to the VP of Quality Assurance and Continuous Improvement with dotted line to the...

  • Activities & Volunteer Coordinator

    Found in: Resume Library US A2 - 2 weeks ago

    Orange, California, 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 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Orange Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that I've...