What are the responsibilities and job description for the Senior Manager, Quality Systems position at Brasseler USA?
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 positionmanages all quality assurance activities for both the dental and medical companies. This is the key individual interpreting all applicable quality and regulatory requirements,providing andensuring acompliant Quality System, and managing the risks of our approach.
KEY RESPONSIBILITIES:
Directs efforts to establish, implement and maintain the Brasseler USA (BUSA) Quality System.
Organizesand promotescompany-wide quality improvements to ensure compliance with customer and regulatory requirements.
Promotesawareness of regulatorycompliancerequirements and impact on BUSA operations.
Developsand implementspolicies and procedures that drive quality responsibility and ownership throughout the organization.
Analyzesand reportson 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 theQuality Management System.
Monitors 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 forBUSAcompany personnel.
Manages the Supplier Quality, product complaint process,CAPA system, auditing program, validation plans,documentcontrol 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.
Cooperates 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 Systemsand 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:
Minimum 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.
7Years, 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 bodiesand 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 - typicallynot 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, stretchand 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.
