Career Opportunity

Quality Operations Manager

HireneXus Category Icon

Category

Manufacturing

HireneXus Job Location Icon

Location

Franklin, Massachusetts

HireneXus Salary Icon

Salary

$120,000 - $135,000

HireneXus JobID Icon

Job Reference

53685

Quality Operations Manager

Job Purpose:

Oversight of Quality Operations activities (Quality Assurance & Quality Control) across the Company’s manufacturing location ensuring compliance to and continuous improvement of the Quality Management System. This leader will be expected to apply his/her knowledge of Quality Assurance and Quality Control principles and techniques to positively collaborate and lead in in the advancement and effective operation of the QMS. In parallel, the candidate shall also ensure QA/QC personnel are adequately trained and developed to advance the business objectives of the Company.

Job Responsibilities:

  • Oversees multiple Quality Control/Quality Assurance (QC/QA) programs and processes within the department and manufacturing facility, including training, managing nonconformances, Corrective and Preventive Actions (CAPA), supplier quality, data review, and reporting, serving as the subject matter expert (SME).
  • Coordinates and facilitates QC/QA activities to ensure timely fulfillment of commitments.
  • Ensures that QC/QA personnel receive appropriate training and maintain competency.
  • Leads the planning, coordination, and/or review of validations for test methods, transfers of test methods, and/or qualification/requalification of equipment, as necessary.
  • Assists in troubleshooting test methods and/or equipment when required.
  • Authors, reviews, and/or approves data, Standard Operating Procedures (SOPs), Certificates of Compliance (COCs), Device History Records (DHRs), and other necessary documents.
  • Monitors, tracks, publishes, and reports QC/QA metrics (Nonconformance Material Reports (NCMR), CAPA, etc.) at Operations meetings. Analyzes QC/QA metrics to identify trends and necessary corrective actions to address adverse trends.
  • Ensures that all QC/QA records and DHR documentation comply with current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP) expectations.
  • Leads compliance-related teams with the objective of continuous improvement.
  • May be required to lead investigations/deviations related to nonconforming materials, Out of Tolerance (OOT) occurrences, and identify corrective actions to prevent recurrence.
  • Acts as an integral part of the Plant Leadership team and serves as the QC/QA representative in cross-functional, cross-departmental working teams.
  • Participates in both internal and external quality audits.
  • Defines appropriate measures to ensure product and process quality.
  • Recruits, mentors, and develops organizational talent.
  • Maintains knowledge of current regulatory requirements and standards pertaining to product development and release, particularly in the medical devices sector.
  • Travel requirements: 25%, including international travel.

Job Qualifications/Requirements:

  • Bachelor’s degree (B.S.) in Engineering, Technical, or Scientific field.
  • Minimum of 8 years of relevant experience, or advanced degree with a minimum of 6 years relevant experience.
  • Minimum of 2 years of managerial experience.
  • Experience leading or supporting FDA inspections and ISO 13485 audits.
  • Good understanding of risk management processes (system risk analysis, Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA)).
  • Prior experience in the medical device industry and with product submissions to regulatory bodies (e.g., FDA) preferred.
  • ISO 13485 Lead Auditor certification preferred.
  • Project management skills preferred.
  • Strong commitment to excellence and high standards.
  • Excellent written and oral communication skills.
  • Strong organizational, problem-solving, and analytical skills.
  • Ability to manage priorities and workflow effectively.
  • Versatility, flexibility, and enthusiasm for working within constantly changing priorities.
  • Acute attention to detail.
  • Demonstrated ability to plan and organize projects.
  • Ability to work independently and as a member of various teams.
  • Proven capability to manage multiple projects and meet deadlines.
  • Ability to develop clear, concise, and timely oral and written reports.
  • Accurate completion of detailed forms and reports.

IND123

Get to know our
Manufacturing Recruiter

Search Jobs

Other Open Positions

15 Apr 2024
RSO / EHS Specialist

Manufacturing

$110,000 - $115,000

Oak Ridge, Tennessee

JOB SUMMARY This position combines the responsibilities of a Radiation Safety Officer with those of an Environmental Health and Safety Specialist. The ideal candidate will possess a strong background in both radiation safety and EHS management, with a focus on maintaining r ....

12 Apr 2024
Production Manager

Manufacturing

$100,000 - $110,000

Wichita Falls, Texas

General job descriptionProduction Manager Our strength is in how we efficiently deliver leading-edge products and support to customers, and we’re proud to set the standard for success in our industry. To help us continue growing, we’re seeking an experienced Pro ....

11 Apr 2024
Procurement Engineer (CA)

Manufacturing

$90,000 - $115,000

Petaluma, California

Procurement Engineer (CA) Job Purpose: To spearhead Sourcing activities focused on new product development and legacy product re-sourcing by collaborating with project managers, design/development engineers and quality engineers where you’ll be required to identify, ....

10 Apr 2024
Procurement Engineer

Manufacturing

$90,000 - $105,000

El Paso, Texas

Procurement EngineerJob Purpose: To spearhead Sourcing activities focused on new product development and legacy product re-sourcing by collaborating with project managers, design/development engineers and quality engineers where you’ll be required to identify, evalua ....

19 Mar 2024
Quality Operations Manager

Manufacturing

$120,000 - $135,000

Franklin, Massachusetts

Quality Operations Manager Job Purpose: Oversight of Quality Operations activities (Quality Assurance & Quality Control) across the Company's manufacturing location ensuring compliance to and continuous improvement of the Quality Management System. This leader will be ....

19 Mar 2024
Quality Engineer (Franklin Site)

Manufacturing

$90,000 - $110,000

Franklin, Massachusetts

Quality Engineer (Franklin Site) Job Purpose: The Quality Engineer plays a vital role in ensuring the quality and safety of Company's products throughout their entire lifecycle. They will leverage their expertise in quality engineering principles, industry standards, and re ....

hireneXus Angle Favicon