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Director, Product Quality

Company: Fresenius Medical Care
Location: Concord
Posted on: September 16, 2020

Job Description:

The safety of our patients, employees, physicians and partners is very important to us. We are actively monitoring the novel coronavirus (COVID-19) pandemic, while ensuring we are continuing to recruit top talent.

As your recruitment journey progresses, you will be utilizing our digital tools, including virtual interviewing. You will receive clear instruction on how to use these tools, and our intent is to provide you with a smooth and well informed experience. Thank you for your interest in joining the FMCNA family!

Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day. These core values are: Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.

PURPOSE AND SCOPE:

Leads and monitors the Operations Quality Organizations for the Concord manufacturing location and seeks out/collaborates/shares best practices between the Concord and Reynosa sites. Ensures compliance to all Federal, State, and local regulations regarding the manufacturing and distribution of medical devices produced. Collaborates with Quality Systems to establish, standardize, and implement required processes at the Concord sites and ensures compliance to them. Responsible for reporting key quality metrics and trends to the site leadership and executive management teams. Provides effective leadership through mentoring and training.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Responsible for all aspects of Operations Quality from Supplier Development through Installation/Service activities including improvements to quality in supplied material, manufacturing assembly, test, and installation/servicing.

Ensures products achieve and maintain acceptable quality levels, including timely and appropriate investigation, correction, containment, disposition, corrective/preventative actions and communications are in place to ensure both product and process quality issues are addressed and patient safety is ensured.

Establishes systems to monitor and improve the quality initiatives and Quality system outputs for effectiveness and efficiency. Works with Corporate, Quality System, and other functional management to develop budgets and long-term planning. Creates and reviews capital expenditure requirements to ensure appropriate facility, test and measurement systems are in place and maintained.

Serves as the Quality System deputy Management Representative and functions as the primary leader for all operations/product quality issues in Concord.

Jointly responsible with Quality System leadership for ensuring that the quality systems is effectively established and maintained according to corporate policies and procedures, and all applicable local, state, federal and international requirements.

Collaborates and strategizes with Sr. Quality Director, Medical Devices on all Operations Quality activities and executes approved strategies.

Seeks out, collaborates, and shares best practices between the Concord and Reynosa sites.

Investigates, assesses and implements new technologies to improve outputs for quality, safety, costs, efficiency, reliability and accuracy.

Develops and maintains fiscally responsible budgets, driving the organization to meet or exceed budgetary commitments while achieving compliance and product quality goals.

Ensures timely and accurate presentation of the key quality performance metrics to Plant personnel and Sr. Management. Assesses the adequacy of overall quality function, including resources and deployment.

Provides leadership and guidance to direct report employees. Works with them to create clear and concise development and succession plans, to ensure the advancement of future leaders and uninterrupted organizational leadership.

Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.

Maintains a highly effective organization, with personnel who are appropriately skilled and motivated to contribute to the success of the company.

Assumes additional responsibilities and performs other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

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

Travel up to 30% required.

SUPERVISION:

Managers, Supervisors and Professionals within the Quality organization.

EDUCATION:

Bachelor's Degree (or higher) in Electrical Engineering, Electronic Engineering, Mechanical Engineering, or a related scientific or engineering discipline required.

Masters in Science (MS) or Business Administration (MBA) preferred.

EXPERIENCE AND REQUIRED SKILLS:

Minimum 10+ years of experience in Medical Device or related industry, including 3+ years of experience leading Quality organizations.

Professional quality discipline certifications (i.e. CQE, CSQE, CQA, CQM, or RAC) desired.

Strong knowledge of FDA and international regulatory requirements, including significant experience working with medical device regulatory agencies.

Ability to present and communicate to all levels of the employees within the organization, including Executive Management.

Excellent leadership skills, including ability to motivate, train and mentor direct reports.

Strong interpersonal skills, with the ability to cross organizational and functional boundaries.

Ability to champion new initiatives and manage implementation effectively and efficiently.

EO/AAEmployer: Minorities/Females/Veterans/Disability/Sexual Orientation/GenderIdentity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

When Hurricane Harvey hit Houston, our team went above and beyond to help dialysis patients.

Dr. Chih-Hu recognized for Outstanding Service Award for biotech Research Manager in Dialyzer Research and Development.

Join Our Talent Network Let’s stay connected! Joining our talent network allows us to send you company news, career event announcements and new job opportunities.

As a company with over 64,000 dedicated employees, Fresenius Medical Care North America is quite aware of the many scams that job seekers may face. If you receive any type of communication on behalf of Fresenius Medical Care North America that seems inappropriate or suspicious, we urge you to report this activity to:

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

If you are a recruitment agency submitting a resume on behalf of a client:

Fresenius Medical Care North America (FMCNA) only accepts resumes from agencies on the preferred supplier list and all third party searches require Human Resources approval. Please do not forward resumes to our applicant tracking system or to FMCNA employees and/or FMCNA Management. FMCNA is not responsible for any fees or charges associated with unsolicited resumes or third party searches conducted without Human Resources approval.

If you are interested in applying for employment with Fresenius Medical Care, NA and require special assistance or accommodation during any part of the pre-employment process, please contact our dedicated Help Desk for assistance at (855) FMCNAHR.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, pregnancy, marital status, national origin, citizenship status, disability, military status, sexual orientation, gender identity, genetic predisposition or carrier status or any other legally protected characteristic.

Keywords: Fresenius Medical Care, Concord , Director, Product Quality, Other , Concord, California

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