Job Description
Senior Manager, Quality Systems page is loaded Senior Manager, Quality Systems Apply remote type Onsite locations Savannah - GA time type Full time posted on Posted 5 Days Ago job requisition id R128762 Don’t just work somewhere, join Brasseler and be a valued team member of a world-class health care organization! Our Culture:
Provides a safe and welcoming environment where team members can balance their lives and develop their careers. All people and experiences are valued and respected. Different perspectives are encouraged and lead to better results. This makes us who we are and enables us to be a world-class healthcare organization. All who join us are accountable to this charge.
Our Philosophy:
Quality products sold with integrity has been the hallmark of Brasseler USA from the beginning. Brasseler USA’s strong reputation of providing high quality, clinician endorsed and innovative dental and medical instrumentation nationally has spanned over 40 years. We have been offering a full-range of products made in the USA since 1976. Many of our products are manufactured at our headquarters in Savannah, GA.
Explore our career opportunities below to learn more.
JOB OVERVIEW:
The position manages all quality assurance activities for both the dental and medical companies. This is the key individual interpreting all applicable quality and regulatory requirements, providing and ensuring a c omplian t Quality System , and managing the risks of our approach .
KEY RESPONSIBILITIES:
Directs efforts to establish, implement and maintain the Brasseler USA (BUSA) Quality System.
Organize s and promote s company-wide quality improvements to ensure compliance with customer and regulatory requirements.
Promote s awareness of regulatory compliance requirements and impact on BUSA operations.
Develop s and implement s policies and procedures that drive quality responsibility and ownership throughout the organization.
Analyze s and report s on the performance of the Quality System through internal audits and trend analysis as a basis for quality improvement.
Performs the responsibilities of the Management Representative for the Quality Management System.
M onitors and analyzes trends in key quality metrics. Reviews results with executive management. Makes recommendations for improvements.
Promotes awareness of and compliance to the QMS.
Responsible for quality system training program for BUSA company personnel.
Manages the Supplier Quality, product complaint process, CAPA system, auditing program, v alidation plans, document control and document change activities.
Drives definition, implementation, monitoring and communication of key Quality System metrics.
Manages Quality staff to support mfg. operations, new product development and business expansion projects.
Supports troubleshooting, root cause analysis, design control, supplier selection and evaluation, to address quality issues.
Evaluates changes in regulatory requirements and make changes in the QMS to adapt to the new requirements.
C ooperates with other managers in formulating and establishing company policies, operating procedures, and goals.
Develop annual quality plans and objectives and ensure commitments are met and effective.
Serve as technical expert of QS, Management Controls for the organization.
Represent QS, Management Controls during regulatory inspections and notified body audit.
Provide inspection support; inspection readiness, execution (front room and back room) and post inspection activities.
Manages the budget for Quality Department.
SUPERVISORY RESPONSIBILITIES
Supervises/ manages the Quality Engineering, Quality Systems and Operations Quality/QC personnel .
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK EXPERIENCE:
M inimum of 5 years Medical Device Regulatory Affairs experience; or equivalent combination of education and experience. Must extensive experience with FDA medical device regulations, ISO 13485, MDSAP, EUMDD/MDR requirements.
7 Years, experience in management is preferred
PREFERRED EDUCATION:
Bachelor's degree (B.S.) from four-year College or university
KNOWLEDGE, SKILLS & COMPETENCIES:
Attract, retain, motivate, coach, and develop team members for high performance
Ability to lead and manage complex projects
Excellent decision making skills
Excellent analysis and problem solving skills
Excellent organizational skills and extreme attention to detail
Demonstrated success in negotiations with regulatory and/or notified bodies and other participants
Excellent written and verbal communication skills (including interaction with both internal personnel and external organizations such as regulatory agencies and customers.
Ability to read, analyze, and interpret technical journals, legal documents, test reports, clinical and medical terminology, technical product information, and complex documents
Strong PC computer skills with everyday experience working with Microsoft products.
Multi-tasking is essential for this position. A high energy level and comfortability performing projects in conjunction with day-to-day activities.
Ability to speak effectively before groups of employees, management, and agency representatives.
Knowledge of quality and regulatory standards, include ISO.
TRAVEL / WORKING CONDITIONS / PHYSICAL DEMANDS:
Travel – typically not more than 10%
Position typically works in an office environment whether on site or remote where environmental conditions are stable
This position will typically
While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 pounds
Benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, Generous Time Off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.
*Benefits may vary by location or status.
Henry Scheinis an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
About Us Over 90 years ago Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York,nearly
30 miles fromMelville, New York, whereour corporate headquarters
resides today.In the depths of the Great
Depression,Henry and his wife Esther made a bold bet on their futureall while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is nowa Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners.
Since our foundingwe have stayed true to Henry and Esther’s values which has allowed ustoevolve, expand, and grow our Company.Now servingmore than1 millioncustomers in 33 countries and
territories,the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes.
We invite you to join approximately 25,000 Team Schein Members,who are critical to our success and are at the core of our Team Schein Values as our founders would have wanted. We live those values by ensuring that our culture focuses on the wellness of our team, which we accomplish byproviding a safe space for individuals to develop and contribute authentically, with opportunities to give back to society and the communities where we live and work.
No matterthe role you are seeking, we encourage you to comebe a part of a team that makes the world a healthier place.
Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of , as a result of a physical or mental impairment, you can request reasonable accommodations.
Please e-mail the appropriate email address below withthe type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.
It is important to us to offer different types of work arrangements. Please see the types we offer below:
Work From Home: Work is performed directly from the TSM's home office.
Hybrid: Time is scheduled between working from a TSM home office and at a company facility, as required.
Onsite: Work is performed exclusively at a company facility.
Field: Position requires traveling to different locations within a specific geographic territory, as assigned.
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Job Tags
Full time, Work experience placement, Work at office, Remote work, Worldwide, Home office, Flexible hours,