Title: Quality Manager

Department: Quality

Reporting to: Top Quality Professional

Basic Purpose and Function: The Quality Manager will oversee all aspects of the Quality System for an ISO 13485 and FDA Registered Medical Device manufacturing facility. This position is also responsible for ensuring that the production goes on in a manner that all established quality-related guidelines and regulations are adhered to and communicated throughout Vonco. He/she identifies methods and technologies to improve quality and productivity and monitors the activities of their subordinates in the planning, managing, implementation pre and post commercialization of Quality Improvement functions and provides resources for completion of these functions.

Job Responsibilities

· Support the manufacturing process, including validation of new processes, develop and implement inspection and test methods

· Create, review and approve ECO’s, document changes and deviations

· Perform DHR’s reviews and release of product

· Develop and manage risk control measures (pFMEA)

· Identify, develop and implement process improvement

· Support New Product Development activities and ensure requirements of design control are met

· Work with other departments to review, train and improve work instructions and procedures within the department

· Responsible for CAPA, complaint and internal audit programs

· Lead a team Quality professionals

· Ensure that the organization’s Quality Management System conforms to customer, internal, and regulatory/legal requirements

· Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products

· Work with customers, employees, contractors, and outsourcing firms to develop product requirements

· Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement

· Conduct annual management review meetings

· Participate in the development of test methods and control plans

· Management Representative for purposes of ISO 13485

Qualifications

· Bachelor's degree from four-year college or university or 3-8 years of quality engineering experience working in the medical device industry

· Understand and apply knowledge of

o ISO 13485, ISO 9001 standards, AIB and SQF. Ideally, experience working in an established FDA Quality System Regulation (QSR- 21 CFR Part 820, 21 CFR Part 210/211)

· Has led or participated in a QMS ISO certification and/or upgrade

· Good laboratory practice (cGLP) and good manufacturing practice (cGMP) experience

· Analytical problem-solving skills with a demonstrated ability to resolve complex issues

· Effectively use risk-based decision making

· Ability to collect, summarize and report technical information

· Computer competency in MS Office - Word, Excel, and Outlook

· Integrity and high ethical standards

· Excellent verbal, interpersonal and written communication skills

· Self-starter, and motivated individual who works independently

· Basic statistical analysis and interpretation of statistical data (i.e. SPC, population testing, confidence intervals.)

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Fortville, IN 46040: Relocate before starting work (Required)

Work Location: In person