Job description

SUMMARY:

We are seeking a qualified and experienced Quality Manager to be responsible for the overall Quality Systems programs, including Audit Readiness, CAPA, etc. This individual will play a key role during inspections and will work with department leaders to remain in compliance and inspection ready at all times. They will also coordinate the internal audit program. The Quality Manager will manage the escalation of quality system data for corrective action and ensure that the CPAR program is effective. In this role they will assist in the trending and reporting of quality systems data and will interface with leaders throughout the organization to drive communication.

DUTIES & RESPONSIBILITIES:

• Define the purpose and objectives and Maintaining the company’s Quality Management System (QMS)

• Participates and provides quality & compliance leadership and enforcement in the design, establishment & maintenance of programs & processes that ensure quality products & services in compliance with 21 CFR 820, MDSAP, ISO 13485:2016& MDD.

• Determines resource and information requirements necessary to support the operation and monitoring of quality system processes.

• Provides assurance over internal activities, as well as quality oversight of suppliers & service providers.

• Review manufacturing and testing documentation including validation/qualifications and other technical documents. Support final review and release of material produced in-house and at contract manufactures.

• Audits Internal, External, and Supplier. Also manage audit schedules.

• Collaborate with functional groups to evaluate and address complex issues such as deviations, complaints, corrective and preventative action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventative action (CAPA) recommendations related to products.

• Serve as a Quality Representative on all new product development project teams.

• The training list is reviewed by the Quality Manager or designee biannually to insure appropriate training of new personnel. In addition, new training requirements are assessed by individual department heads and communicated to the Quality Manager.

• Identify quality assurance metrics; analyze and report trends to site Operations management.

• Participate as Quality subject matter expert in the review of product requirements, design requirements, software requirements specifications, and functional specifications.

• Ensure that receiving, in-process, and final inspection and testing are conducted according to Standard Procedures and Work Procedures.

• Review, approve and coordinating the implementation Engineering Change Order (ECO).

• Additional tasks and projects as assigned.

QUALIFICATIONS:

• B.S. degree in Industrial or Mechanical Engineering or a related field.

• 5-10 years’ experience running a Quality department, in the medical or medical device industry highly preferred.

• Strong understanding of ISO-13485, MDD and CSA requirements for engineering. Understanding of Safety and EMC standards.

• Must have excellent communication skills, be detail oriented with effective problem-solving skills.

• Must be highly organized and able to handle multiple priorities in a fast-paced environment.

• Prior supervisory experience needed.

• Familiarity with various manufacturing systems, MS Office and advanced excel skills necessary.

Job Type: Full-time

Pay: $100,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay
• Signing bonus

Education:

• Bachelor's (Required)

Experience:

• Quality management: 5 years (Required)
• Quality Department management: 5 years (Required)
• ISO 13485: 5 years (Required)
• 21 CFR 820: 5 years (Required)
• CAPA: 5 years (Required)
• Medical Device manufacturing: 1 year (Required)

Work Location: In person

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