Quality Assurance Manager

Cepheid Hatfield , PA 19440

Posted 6 months ago

Position Summary:

Quality Assurance Manager will ensure the appropriate licensing, marketing and legal compliance of medical products. Manager has the combining knowledge of scientific, legal and business issues, to enable products that are developed, manufactured or distributed by KaVo Kerr to meet the required legislation. The Quality Assurance Manager is the crucial link between KaVo Kerr, its products and regulatory authorities, including the US Food and Drug Administration (FDA), local and state agencies and International agencies.

Essential Duties and Responsibilities:

  • Ensure that the company's products comply with the US Food and Drug Administration (FDA), local and state agencies and the International agencies regulations.

  • Keep up to date with international legislation, guidelines and customer practices.

  • Act in capacity of Management Representative who, irrespective of other duties, has the responsibility and authority for ensuring the processes of the quality system are in place and maintained, and for reporting on the performance of the quality management system, along with any needed improvements. The Management Representative also has the defined responsibility for promoting awareness of quality, regulatory and customer requirements throughout the organization. The management representative will prepare, schedule, and conduct the management review.

  • Ensure that the requirements of Danaher GMP Internal Audit Procedure DRC-001 are met by providing written responses to identified site audit deficiencies and corrective/preventive actions, as well as closing all observations on time.

  • Responsible for the local Quality Management System, including review and approval of SOP's and associated engineering and operational documentation.

  • Lead the continuous quality improvement process, including the trending of quality data and leading the CAPA process. Ensure CAPA's are properly documented, entered into the CAPA database and assigned to appropriate owners. Review investigation/root cause analysis to ensure they are appropriate.

  • Oversee Customer Defect & Resolution process, including the gathering, analysis and reporting of statistics and identify methods and systems to address deficiencies. Proactively communicate information to management.

  • Manage the Quality Assurance department, including personnel responsible for complaint management, inspection, calibration and document control.

  • Manage the Internal Audit Program.

  • Work with project teams and colleagues involved with the development of new products to ensure quality and compliance objectives are established and achieved

  • Responsible for adverse event reporting and recall management.

  • Lead quality and continuous improvement efforts across the business by utilizing trend data and the CAPA process

  • Oversee processes and quality system related to Customer Service & Technical Support Call Center in Alpharetta, Ga.

  • Performs other duties and task as assigned by supervisor/manager

Other duties as assigned:

  • Experience in leading subordinate staff to high levels of compliance.

  • Project management skills Experience leading projects and managing sustainment.

  • Knowledge of the process of establishing facility QMS certifications

  • Experience in the strategic planning of quality/compliance processes and objectives.

  • Proficient in the use of a computer, MSOffice suite knowledge/experience required.

  • Previous experience in successful leadership and communication.

  • Ability to apply problem solving mindset in various settings.

  • Able to successfully work in a structure with off-site leadership.

  • Able to communicate to all levels within the organization.

  • Able to interpret regulatory requirements and establish practical solutions within a dynamic business environment.

  • Experience in leading continuous improvement efforts, in both quality systems and products.

Requirements:

  • Bachelor's Degree in engineering, electronics or relevant field required; a combination of education and 15 years of experience may be considered in lieu of degree.

  • 5 years of experience in Quality Assurance setting.

  • 4 years of experience in Quality setting with FDA regulations and/or ISO standards.

  • 2 years of experience managing complex projects.

  • Proficient in the use of a computer, MSOffice suite knowledge/experience required.

  • 2 years of experience in comprehensive ownership/leadership of most aspects of a Medical Device Quality Management System, Proven expertise in appropriate FDA, QSR and ISO regulations: design controls, production/process controls, regulatory approval methods.

  • 2 years of leadership experience including influencing people, mentoring and leading direct reports to high levels of compliance.

Preferred Qualifications:

  • Master's degree

  • Experience performing the duties of Management Representative

  • Ability to apply problem solving mindset in various setting

  • Able to successfully work in a structure with off-site leadership

  • Able to communicate to all levels within the organization

  • Able to interpret regulatory requirements and establish practical solutions within a dynamic business environment.

  • Experience in leading continuous improvement efforts, in both quality systems and products

  • Experience with root cause analysis, DOE, statistics, lean manufacturing and six sigma

  • Knowledge of the process of establishing facility QMS certifications

  • Experience in the strategic planning of quality/compliance processes and objectives

  • Track record for successfully driving multi-faceted cross functional projects, including CAPA projects

  • Excellent problem solving and presentation skills, as well as the ability to learn a new environment quickly.

  • Cross functional experience with products, engineering processes and manufacturing processes to maintain credibility to communicate and influence change at all levels within the organization.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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IND-KAV1


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Quality Assurance Manager

Cepheid