6 hours

Sr. Manager, Quality Assurance (AUS)

NuVasive
  • Job Code
    101271
Sr. Manager, Quality Assurance (AUS) - External Careers

Sr. Manager, Quality Assurance (AUS)

APAC, Australia, Australia

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: Up to 25%

Location: Australia

Ref#: 101271

Job Description

Summary: 

Ensure site-wide compliance (establishment, implementation, and effectiveness) with the Quality System, GMP, and ISO regulations and standards. Support Quality System reporting to management and drive continuous improvement projects.

 

 Essential duties and responsibilities include the following. Other duties may be assigned.

  • Facilitates the coordination of teams to formulate new programs, company policies and operating procedures. Lead other personnel to establish, delineate, and review organizational policies, coordinate functions and operations between departments and to establish responsibilities and procedures for attaining objectives.
  • Works closely with Regulatory and Quality management in the identification of Quality System and Regulatory initiatives, including audit remediation and corrective action efforts, regulatory changes, organizational expansion and other necessary projects to assure organizational compliance and scalable infrastructure in alignment with organizational goals and objectives.
  • Supports and facilitates the development, review and approval of new Quality System documents and procedures to assure the compliance of the NuVasive Quality Management System to relevant domestic and international regulations and standards.
  • Provide support to ensure that quality system activities are in place and are conducted in accordance with applicable regulations and standards including, but not limited to ISO (International Organization for Standardization) Standards, and the European MDD (Medical Device Directive)/MDR (Medical Device Regulation). 

In conjunction with other QA department management:

  • Support initiatives to address compliance trends and drive continuous improvement.
  • Ensures constant readiness for compliance audits or inspections by regulatory agencies or quality system standards organizations, by ensuring documentation for all associated programs is current.
  • Ensures the analysis and presentation of information to executive management concerning measures of product, process and service quality.
  • Ensures appropriate quality system training is conducted for all site cGMP-impacted areas as applicable.
  • Other functions include the development of new quality initiatives, ensure quality system development and management remains in line with organizational objectives, including the development or organizational systems, procedure writing and review, and the management of initiatives designed to improve quality and reliability of products.
  • Mentor, develop and guide subordinates using management and cultural tools and resources and drive team engagement and performance to ensure company goals and objectives are achieved.

Supervisory Responsibilities: Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; motivating, rewarding and disciplining employees; addressing complaints and resolving problems. 

Basic Qualifications

Requirements: 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.

Education and/or Experience: A minimum of 5 years related experience in the medical device field is required. Bachelor’s degree is preferred. Must have knowledge of QSR and ISO 13485, MDD, and experience with medical device components. Familiarity with 21 CFR Part 11 Electronic Records; Electronic Signatures, and software validation. Up-to-date knowledge of international directives and regulations (e.g. EU Medical Device Directive) applicable to NuVasive operations and business objectives. Experience in a regulated environment in Quality Assurance and or Manufacturing/Engineering (design) environment. 

Computer Skills:  Proficient and accurate with word processing (Word), spreadsheets (Excel), Outlook, IE Adobe Acrobat, and Visio; experience with SAP preferred.

Language Skills: Fluency in English required. Ability to read and interpret documents such as safety rules, company policy and procedure manuals. Ability to write business reports and correspondence. Ability to speak effectively before groups of customers, employees, and management of organization.

Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.

Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to walk and reach with hands and arms.

Work Environment: The 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. 

 

 
Preferred Qualifications

N/A

NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available . NuVasive's EEO policy is available . 
 
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit .

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Posted: 2019-10-21 Expires: 2019-11-20

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