Quality Assurance Manager

Job Description

The Quality Assurance Manager will be responsible for creating and establishing processes and metrics to successfully manage and improve performance of the company. This leader will partner closely with our Marketing, Sales, Events, Member Success and Customer Service departments to improve overall operational performance. This position will report to the Global Senior Director of Sales Operations with operational support from Global Quality Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Ensures effective QMS oversight- this will include review and implementation of current and new processes and procedures as per ISO 9001 and corporate procedures.

· Directly responsible for implementation and maintenance of the company quality management system and helping to drive improvement / harmonization of processes throughout the facility while working in conjunction with the Global Quality Systems Department and in line with corporate procedures.

· Supports existing and new business generation.

· Organizes and promotes companywide quality improvement efforts, communicating expectations and standards.

· Executes and participates in all audit activities related to notified bodies and local regulatory authorities.

· Supports quality audits for vendors which have a global impact for the company.

· Supports all departmental monthly metrics and advises departmental managers/directors of QMS requirements as required.

· Responsible for all customer complaints management and monitoring for adverse events.

· Ensures compliance with regulatory standards.

· Supports various talks or presentations as deemed necessary by Senior Management.

· Manages the day-to-day technical issues through effective interaction with all departments.

· Monitors and reports adverse events in collaboration and in compliance with Global Quality Systems Manager.

· Assists when requested in the management, preparation and submission for existing and new product lines, utilizing experience for the U.S.

· Performs all other duties as assigned.

PHYSICAL DEMANDS

While performing the duties of this job the employee is regularly required to remain in an office at a computer work station and access information from a computer. The employee is required to be mobile to, from, and within the office. The employee may occasionally move up to 25 pounds.

QUALIFICATIONS AND EXPERIENCE

· Bachelor’s Degree in Science, Engineering or similar technical discipline is required.

· At least 3-5 years’ experience in GMP, encompassing Quality Management or Compliance role is required.

· In depth knowledge of ISO 13485/ISO 9001 and related FDA 21 CFR requirements is required.

· Experience leading a function or key quality projects or aspects in a commercial operation is required.

· Experience supporting the introduction of new products.

· Working knowledge of FDA is required.

· Must have proven ability to influence across functional departments and at senior levels, building strong networks internally and externally.

· Strong technical capabilities, communication skills, teamwork abilities and initiative are expected.

· Proven ability to manage complex quality issues and deliver against quality strategies.

· Must be a self-starter, with ability to perform in a stand-alone role, i.e. to work autonomously with minimal supervision.

Job Type: Full-time

Pay: $100,000.00 - $110,000.00 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Draper, UT: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 13485: 2 years (Required)

Ability to Relocate:

• Draper, UT: Relocate before starting work (Required)

Work Location: In person

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