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Quality Manager

2 months ago

Halifax Regional Municipality, Canada Volt Full time

You miss 100% of the jobs you don’t apply for

Volt is immediately hiring a Quality Manager in Hawthorne, CA.

As a Quality Manager, you will:

  • Responsible for the Quality team to focus on supporting, maintaining, and improving our ISO 13485-certified Quality Management System (QMS).
  • Own or support several key QMS processes, such as internal audits, document management, or copy review.
  • Work to incorporate quality assurance capabilities and methodology throughout the organization.
  • Directly interact with many internal and external stakeholders, including Engineering, leadership, and regulators, to develop or maintain quality processes for our medical device initiatives.
  • Establish overall short and long-term quality strategy and objectives.
  • Provide leadership and direction to the quality team to ensure adherence to quality standards and compliance with regulatory requirements to ISO 13485, 21 CFR 820, MDD/MDR, MDSAP, etc.
  • Collaborate with cross-functional teams to drive continuous improvement initiatives and address quality issues in a timely manner.
  • Drive cross-functional collaboration and engagement in creating, implementing, and driving QMS policies and procedures. Ensure training plans as required.
  • Develop strategic fit-for-purpose plans and policies to ensure seed product quality meets customers’ expectations.
  • Ensure a proactive quality culture so that customers receive the product to the highest quality and reliability standards; study industry benchmarks and define the metrics required to assess performance.
  • Report on Quality activities on a regular basis to the Senior Management team, ensuring accurate and timely reporting of the relevant Key Performance Indicators.
  • Work with suppliers and manufacturing to meet quality target goals, and drive issue resolution for quality problems.
  • Foster a culture of quality and promote awareness of regulatory requirements and best practices across all departments.
  • Own, support, and improve specific QMS processes and procedures.
  • Develop and implement quality metrics and key performance indicators (KPIs) to monitor the effectiveness of the QMS and identify areas for improvement.
  • Lead and participate in various quality projects and initiatives, driving continuous improvement efforts within the organization.
  • Deliver updates to executive management on a regular basis.
  • Provide coaching and mentorship to quality staff, building and developing a high-performing team. Set clear performance expectations and objectives.
  • Implement methods to inspect, test and evaluate products and production equipment.
  • Ensure that products adhere to quality standards.
  • Track products through the manufacturing process to guarantee that each part of the process is correct.
  • Support other Quality and Regulatory tasks, initiatives or other activities as required.

This is a full-time, Direct Hire opportunity.

The ideal candidate will have:

  • At least 10 years of experience in a regulated industry such as medical device or pharma with a minimum of 5 of these years in a leadership position.
  • Minimum of 5 years of experience in a manufacturing environment.
  • Demonstrated understanding of FDA regulations, including 21 CFR Part 820, and relevant international standards, such as ISO 13485.
  • Expert understanding of Quality Management System principles and implementation methodologies.
  • Expert understanding of Equipment and Process Validations.
  • Strong knowledge of Advanced Product Quality Planning (APQP) activities including PFMEA, and PPAP requirements.
  • Strong leadership skills, including coaching, team-building, training, and conflict resolution.
  • Proven ability to build and lead high-performing teams, fostering a collaborative and proactive work environment.
  • Excellent communication, interpersonal, and presentation skills.
  • Meticulous attention to detail and ability to manage multiple priorities effectively.
  • Strong organizational and strategic management skills.
  • Strong analytical and problem-solving skills with a data-driven approach to quality improvement.

Salary: $125,000K - $135,000K

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Since this is a Direct Hire role, benefits will be provided by the employer.

Qualified candidates should APPLY NOW for immediate consideration Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.

Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

JD

Volt is acting as an Employment Agency in relation to this vacancy.

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