Senior Quality Engineer, Contract Manufactured Product

Sectors:
Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Locations:
International
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
17/09/2020
Start Date:
ASAP
Recruiter:
AtriCure, Inc.
Job Ref:
950236269

This Senior Quality Engineer, Contract Manufactured Product role works closely with Contract Manufacturers, AtriCure engineering, manufacturing, supplier quality, and suppliers to ensure that quality system activities are completed.This individual will have a strong technical foundation and must be able to lead and coordinate activities related to daily operations.This individual will operate regularly with a cross functional team and shall contribute to the creation of a collaborative work environment. The job performance requires advanced technical abilities as well as an understanding of product design, manufacturing and quality systems.

ESSENTIAL FUNCTIONS OF THE POSITION:

Provides Quality Engineering support for products generally acquired as finished devices (less some value-added operations).The products within this category will require routine collaboration with key contract manufacturers, suppliers and internal functions.Daily tasks require the timely addressing of product line issues through correction and prevention processes.

With respect to direct product responsibility, the Sr QE for Contract Manufactured Product manages, and coordinates required activities from external (contractor and supplier) and internal functions (ie. Engineering, Manufacturing, Quality, Inspection, Document Control) and processes (ie. Product qualification, process validation, NCRs, FMEA's, Rework, Deviations)

Chairs the MRB for respective product line.

Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with minimal guidance from management, and resolves problems/conflicts.

Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required.Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer

Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.

Assists with 3rd party, internal, and external FDA and ISO audits, as necessary

Assists in the further development of quality engineers.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

Regular and predictable worksite attendance [removed for field-based jobs]

Ability to work under fast-paced conditions

Ability to make decisions and use good judgment

Ability to prioritize various duties and multitask as required

Ability to successfully work with others

Additional duties as assigned

BASIC QUALIFICATIONS:

Bachelor's degree in Engineering required or demonstrated equivalent combination of education, training and experience

5+ years of experience

Knowledge/experience working with contract manufacturers of finished devices.

Knowledge/experience with sterile packaging of disposable medical devices.

Knowledge/experience with EO and Gamma sterilization validation and continuous monitoring.

Proficient in interpreting design drawings (including GD&T) and product specifications

Test Method Validation/Gage R&R experience

Problem Solving/Troubleshooting experience

Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc.

Strong interpersonal, organizational, and communication skills.

Verbal communication and people skills

FDA and ISO 13485 knowledge

Metrology background

Auditing experience

Data analysis experience

Computer/data entry skills

Written/report writing skills

Experience with industrial or manufacturing statistics

Ability to travel 25%

PREFERRED QUALIFICATIONS:

MDD, CMDR and JPAL knowledge

ASQ Certified Quality Engineer and/or Auditor

Supervision experience

Regulatory experience

Engineering/design background

Experience training production associates, inspectors, and training/mentoring junior engineers.

Closing Date:
15/10/2020
Contact Details:
AtriCure, Inc.
Contact: Click apply

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