Quality Manager

Position: Quality Manager
Department: Engineering
FLSA Status: Exempt
HQ Location: Scottsdale
Remote Work: Hybrid / Remote
Report to: Senior Director of Engineering
Salary/Pay:  $85,000 – $120,000
Direct Reports: Yes

Job Description

The role of Quality Manager at Jupiter Research will include utilizing critical thinking and statistical methodologies to evaluate and investigate product defects in order to resolve customer complaints and improve product quality while maintaining the integrity of the quality management system. This role will also be responsible for collaborating with the research team to identify possible quality improvements and develop thorough testing protocol to validate possible product changes.

Responsibilities/daily tasks:

• Evaluate business goals, identify improvement opportunities, and apply scientific methods, statistics, and problem-solving techniques to improve and sustain product quality and process effectiveness.
• Investigate possible design improvements as it relates to product quality.
• Understanding customer needs and requirements to develop effective quality control processes.
• Creating and reviewing specifications for products or processes.
• Establish statistical confidence by identifying sample size and acceptable defects; determining levels of confidence.
• Development, maintenance, and improvement of the Jupiter Quality Management System as it relates to ISO 13485:2016 and Regulation MDR 2017/745.

• Support in the development, maintenance, and improvement to Jupiter’s internal training program including new hire onboarding, continuous training of internal personnel, review and retention of training records, and traceability to ensure visibility as it relates to ISO 13485 and MDR 2017/745.

• Management Representative (MR) for ISO standards and responsibilities, including:

  • Ensuring implementation and maintenance of key standards and guidelines.

  • Reporting back to top management on performance metrics and output data.

  • Promoting awareness of regulations and expectations across the organization through strong communication and messaging.

  • Serving as a quality liaison with external parties regarding the QMS

• Drafts and maintains programs, policies, and procedures to evaluate quality and performance of Jupiter product and customer processes.

• Prepare and present reports pertaining to product improvement and quality to the management team by collecting, analyzing, and summarizing test data.

• Plan and execute projects and team activities to facilitate changes that have a statistical impact on business results, especially as it relates to meeting and exceeding customer expectations.

• Provide customer support to determine root cause and identify possible solutions to product defect complaints.

• Implement and maintain internal corrective and preventative actions.

• Assist manufacturer with development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results.

• Signing authority for all Quality Related compliance and QMS documents, shipping and activities.

• Work directly with the manufacturer to improve product and manufacturing process quality.

• Quality Manager may assume the responsibility of ‘Person Responsible for Regulatory Compliance’ (PRCC) per MDR Article 15 / Management Representative.

  • The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.

  • The technical documentation and the EU declaration of conformity are drawn up and kept up to date.

  • The post-market surveillance obligations are complied with in accordance with Article 10(10)

  • The reporting obligations referred to in Articles 87 to 91 are fulfilled.

  • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Qualifications: Experience, Education

• Diploma, certificate or other evidence or formal qualification awarded on completion university degree or a course of recognized as equivalent by the Member state concerned in: law, medicine, pharmacy, engineering, or other relevant scientific discipline etc. and at least one year of professional experience in Regulatory affairs or in QMS relating to Medical Devices.

• Or four years of professional experience in regulatory affairs or in Quality Management systems related to Medical Devices.

• 5+ years of experience with Quality Assurance programs.

• 4+ years of manufacturing environment experience.

• 4+ years of experience in an ISO-9001 / ISO 13485:2016 QMS.

• Experience with method development and optimization.

• Experience working in cross-disciplinary teams.

Preferred Competencies:

• Functional Acumen Consistently shows comprehensive knowledge, skills, and abilities in the functional area(s) for which they are responsible, and understands the fit with overall business goals

• Emotional Intelligence – Consistently executes the four (4) principles of EQ (i.e., self-awareness, social awareness, self-management, relationship management)

• Intellectual Agility: Consistently evaluates challenges and opportunities from a variety of angles, taking in multiple inputs, and arrives at reasonable business decisions

  Leadership:

• Lead – Able to inspire others through words and actions to achieve a common goal, and meets or exceeds targeted business results

• Manage – Able to get specific tasks done through others, and meets or exceeds targeted business results

• Coach & Develop – Able to observe the job performance and conduct of an employee, identify the employee’s strengths and areas for improvement, and formulate approaches to enhance the employee’s output, job satisfaction, and commitment to the company.

• Collaborate – Consistently maintains effective teaming relationships with internal parties, and as applicable, external parties.

• Dependable – Can be consistently trusted to execute their job responsibilities on-time and within scope, and meets or exceeds targeted business results.

• Upholds Company Values – Consistently role-models and supports execution of the Company core values.

Compensation & Benefits:

• Competitive base salary
• Health, dental, and vision insurance
• Paid time off and holidays
• Opportunities for growth in a rapidly expanding industry

The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job.  The above is not intended to be an exhaustive list of all responsibilities and duties required.

TILT is an Equal Opportunity Employer Committed to DEI.  All qualified job applicants receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are committed to fostering diversity and leveraging the value of diversity with equity and inclusion.

For Company information, visit: www.tiltholdings.com