Director, Quality Assurance - Manufacturing

Don’t just work somewhere, join Brasseler and be a valued team member of a world-class health care organization!

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.

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.

This position is responsible to develop, implement and direct the company’s quality assurance policies, procedures and methods to evaluate and improve the quality of complex products, materials, components and/or operations using standard procedures (e.g. 9001:2015, ISO 13485:2016, QMSR, etc.) , and may take all reasonable and prudent steps necessary to maintain compliance with company and product registration requirements, with appropriate notification to, and/or direction from their direct supervisor .

• Direct all phases of highly technical quality assurance audit activities.
• Oversee the Quality Management Systems of multiple entities ensuring compliance with global MDSAP requirements as applicable.
• Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals.
• Direct and oversee Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits and follows
  -up on CAPAs/Observations.
• Oversee suppliers to assure the quality of their products, materials, components and/or operations.
• Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process.
• Stay current with new or potential business opportunities, and prepare for all QA activities.
• Direct and oversee the research for applicable FDA, ISO and ASTM /ANSI standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives , Medical Device Regulations, and FDA QS requirements).
• Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities.
• Serve as the Management Representative for the site for interaction with regulatory agencies.
• Serve as Person Responsible for Regulatory Compliance (PRRC) at manufacturing locations for Corporate Brand products, under the European Medical Device Regulation.
• Assist with due diligence and follow-up surveillance audits as required and serve as SME for some manufacturing partners.
• Assess the effectiveness of existing policies, guidelines and procedures and recommend changes.
• Consult and direct process and product transfer projects compliant to the applicable regulations, directives, and standards. Provide ongoing direction and guidance to the team and provide guidance and development opportunities as needed.
• Select, develop, and evaluate TSMs to ensure the efficient operation of the department.

• Knowledge of ISO 9000 certification and maintenance.
• Knowledge of ISO 13485 certification and maintenance.
• Knowledge of the European Medical Device Regulation 2017/745.
• Knowledge of US FDA Quality Management System Regulation.
• Knowledge of MDSAP country specific regulatory requirements.

• Outstanding management and leadership skills and ability to attract, retain, motivate, develop, mentor and coach team members for high performance.
• Outstanding verbal and written communication skills and ability to resolve disputes effectively.
• Outstanding…