Quality Assurance Manager - Draper, United States - LifeWave, Inc

Description

POSITION SUMMARY

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

SUPERVISORY RESPONSIBILITIES

Oversee 1 to 2 employees

Ensure individual performance levels are met

Ensure and report department KPIs

ESSENTIAL DUTIES AND RESPONSIBILITIES

Ensures effective QMS oversight for Utah facility - 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 LifeWave Global Quality Systems Department and in line with LifeWave corporate procedures.

Supports existing and new businessgeneration.

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

Executes and participates in audit activities that pertain to the defined departments

Supports quality audits for vendors which have a global impact for LifeWave.

Support claimsand adverse reporting

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

Acts as management representative for Notified Body and Regulatory Body Audits.

Ensures compliance with regulatory standards.

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

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 workstation 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

Bachelors 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

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

Experience supporting the introduction of new products.

Working knowledgeof 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.

Six Sigma experience and knowledge. Green belt or more preferred

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.