Job Listing

JOB DESCRIPTION

SUMMARY DESCRIPTION:

Position will have responsibility for Quality Engineering activities to support new product introduction, factory ramp into mass production, and continuous process improvement in manufacturing.  This position primarily supports the Medical Technology sub-division. Under limited supervision, incumbent performs activities related to the design, manufacture, and reliability of our MedTech devices.  In many instances, this position must represent the company with respect to product design, manufacture, and reliability – at corporate headquarters, customer, and manufacturing sites.  Quality engineering work assignments are varied and require a results-driven approach.  Incumbent must be comfortable analyzing complex situations and then presenting results concisely, to all levels and manner of audiences.  A strong engineering background is critical, and the ability to travel internationally is required.

SPECIFIC DUTIES AND RESPONSIBILITIES:

1.  Primary Quality contact in project teams and with customers (external and internal) for support across NPI, sustaining, and field support phases.

2.  Assure that all customer requirements are incorporated into the new products and processes.

3.  Ensure compliance with applicable FDA regulations (21 CFR 820), ISO 13485, and other relevant standards.

4.  Support design assurance activities including risk management, design reviews, and verification/validation testing.

5.  Assist with “change implementation” and the objective to transition the organization from a reactive to a proactive culture, to better meet internal and external customer requirements.

6.  Collaborate with global teams to implement and monitor supplier quality, process validation, and product performance metrics.

7.  Translate Voice of the Customer (VoC) into actionable quality and product improvements.

8.  In collaboration with cross-functional teams: Lead project risk assessments, FMEA reviews, customer quality requirement reviews

9.  Drive complaint investigations, CAPA, and root cause analysis in collaboration with internal and external teams.

10.  Take initiative developing and leading cross functional teams to address critical product issues – with regards to both existing products and new product development.

11.  Interact with functional groups at all levels (R&D, manufacturing, sales, marketing, etc.), to address and resolve critical product and customer issues.

12.  Participate in or lead customer audits, inspections, and quality reviews.

13.  Recommend and drive improvements to products & processes in manufacturing.

14.  Propagate the use of statistical techniques in design and manufacturing.

15.  Actively seek out and utilize technical expertise from within the company and from outside sources to assist in problem solving.

Required Qualifications:

•  Bachelor’s degree in mechanical/ electrical engineering, or related technical discipline.

•  Minimum 3–5 years of experience in Quality Engineering within the Medical Device industry.

•  Strong knowledge of Electronics and Electrical Components, Statistical Techniques, Design of Experiments, FDA QSR (21 CFR 820), ISO 13485, and other applicable regulatory requirements.

•  Experience with CAPA, complaint handling, risk management, and design control.

•  Excellent communication skills with proven ability to interact effectively with customers, auditors, and cross-functional teams.

•  Must be experienced in the use of Minitab or equiv.

•  Must be able to travel to customer or internal sites.- 10% travel.

Preferred Qualifications:

• Certified Quality Engineer (CQE), Certified Auditor (CQA), or Six Sigma certifications.
• Experience with Class II or Class III devices, including software-enabled or combination products.
• Familiarity with ISO 14971, IEC 62304, and EU MDR is a plus.
• Experience working with offshore manufacturing and supplier quality teams.