Sr. Director, Quality Assurance & Regulatory Affairs

Cepheid Cincinnati , OH 45201

Posted 3 weeks ago

Mammotome (also known as Devicor Medical Products, Inc.) is a world leader in the field of breast tissue biopsy. The Senior Director of Quality Assurance and Regulatory Affairs (QRA) leads the quality and regulatory functions in all globally served markets (50) and is as a key member of Mammotome Leadership Team. Provides leadership and direction through managers and senior professional staff. This role will be accountable for the performance and results of the global QRA team, including all aspects of quality assurance, quality systems, product quality, quality engineering, regulatory affairs, and compliance. Serves as a business partner who effectively leads QRA while also contributing to the overall success of the operating company.

ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES):

Responsibilities:

  • Senior leadership of the Mammotome quality assurance and regulatory affairs organization across the all applicable sites including: Cincinnati OH, Tijuana Mexico and China

  • Is accountable for the performance and results of the QRA organization including, but not limited to: compliance, product quality, quality engineering, growth initiatives (i.e. registrations, submissions, supporting clinicals), talent & organizational development, and departmental objectives

  • Develops strategies and plans to meet performance objectives of the organization.

  • Ensures that all Mammotome operations comply with applicable quality system requirements including but not limited to ISO 13485 and 21 CFR 820.

  • Effectively delegates initiatives and tasks.

  • Member of the Mammotome senior leadership team and reports dotted-line to the Mammotome President

  • Member of the LBS QRAC management team with responsibilities for tracking and reporting KPIs and driving improvement of performance metrics. Responsible for global QRAC initiatives, as assigned.

  • Support Director of Customer Experience and all service teams to ensure best in class customer experience and prompt issue resolution around all quality related issues.

  • Drive product quality improvements (e.g. PPM) to best in class levels for medical devices through using Danaher Business System and QMS compliant techniques.

  • Lead and develop the Mammotome QRA team according to the Danaher Leadership Anchors (e.g. Charts the Course, Builds Teams, Drives Innovation, Acts with Integrity). Responsible for developing associates through continuous development planning (D4G); drive successful and measurable employee engagement. Hires, trains, and manages department staff and activities to ensure high performance, accountability, interdependence and collaboration.

  • Manage timelines, budgets and resource allocation according to requirements of the business

  • Effectively lead through Danaher Business System (DBS) tools to drive continuous improvement

Critical Success Factors:

  • The ideal candidate possesses superior problem-solving skills, is detail- and process-oriented, and demonstrates the ability to work collaboratively in difficult situations across the organization.

  • The ability to drive process rigor, accountability, and execution both personally and with the global QRA team.

  • Possesses a proactive, entrepreneurial mindset and drives continuous improvement across all areas of responsibility.

  • Is even keeled and thrives under pressure.

  • Has a profound sense of urgency and understands the impact of poor quality on growth and associate engagement.

  • Demonstrates the ability to lead a team, execute on development of team members, and proactively manage associates who are underperforming.

  • Shows excellent cross-functional communication skills both up and down and deals with organizational conflict in a productive and effective manner. Is exceptionally clear and concise.

Required Skills/Experience:

  • Between 10 and 15 years experience with increasing responsibility in medical device QA/RA, depending on educational background.

  • Related experience must include 8 years managing people in a global environment

  • Experience with medical device registrations in global markets (e.g. US, Canada, EMEA, Asia Pacific, Latin American)

  • Professional certifications (i.e., CQM/OA, CQE, AAMI) strongly preferred.

Education

  • Bachelor's degree in engineering, medical or technical field and 15 years' experience with increasing responsibility in medical device QA/RA, or

  • Graduate degree in engineering, medical or technical field and 10 years' experience with increasing responsibility in medical device QA/RA

Travel Requirements

  • 25% travel with a mix of domestic and international locations

  • Frequent/Occasional overnight trips

Physical Demands & Working Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical demands: While performing the duties of this job, the employee is occasionally required to walk, sit, stand, use hand to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance, stoop, bend, talk and hear.

  • The employee must occasionally lift and/or move up to 20 pounds.

  • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

  • This position will require heavy travel by car and flying in and out of airports with possible long wait times.

Work environment: While performing the duties of this job, most work is in an office environment setting. Lighting and temperature are adequate. The noise level in the work environment is usually quiet to moderate.

  • Add any info about electrical hazards, cement floors, operating forklifts, moving mechanical parts, etc.

  • May be requested to work overtime and weekends for special program events

About Mammotome:

At Mammotome, we are committed to providing best-in-class technology to help clinicians accurately diagnose breast cancer. We provide clinicians devices spanning the breast cancer diagnostic care continuum from tissue biopsy to accurate lesion removal, never forgetting that at the heart of each breast cancer diagnosis is the patient. Through our ever-expanding product portfolio we strive every day to improve the patient's journey and achieve better outcomes. Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world.

Diversity & Inclusion

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page

Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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VIEW JOBS 3/5/2019 12:00:00 AM 2019-06-03T00:00 Mammotome (also known as Devicor Medical Products, Inc.) is a world leader in the field of breast tissue biopsy. The Senior Director of Quality Assurance and Regulatory Affairs (QRA) leads the quality and regulatory functions in all globally served markets (50) and is as a key member of Mammotome Leadership Team. Provides leadership and direction through managers and senior professional staff. This role will be accountable for the performance and results of the global QRA team, including all aspects of quality assurance, quality systems, product quality, quality engineering, regulatory affairs, and compliance. Serves as a business partner who effectively leads QRA while also contributing to the overall success of the operating company. 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Sr. Director, Quality Assurance & Regulatory Affairs

Cepheid