Supplier Quality Engineer job Bradenton Florida
Supplier Quality Engineer job Bradenton Florida
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Supplier Quality Engineer Job

Employer Name: EIR Network SpiderID: 8918324
Location: Bradenton, Florida Date Posted: 9/4/2019
Wage: 80000.00 Category: Manufacturing
Job Code:
Number Of Openings: 1

Job Description:
The primary job responsibility for the Supplier Quality Engineer is overseeing the day-to-day functions of Company Orthodontics supplier control activities. This includes but is not limited to leading quality initiatives with suppliers to improve purchased part/service quality, drive quality system improvements, and ensure compliance to regulatory and procedural requirements.

In addition to supplier control activities, this position is also responsible to drive the Co. Orthodontics CAPA, SCAR, and Internal Audit programs.

This job function directly affects product quality.


Interface with supplier and distributor engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements;
Maintain and monitor approved supplier and distributor lists (ASLs) in compliance with procedures (including leasing supplier audits);
Lead supplier new part qualification activities, including development of capability studies and control plans that define the supplier’s processes and identify areas of risk. Review and approve engineering design changes and supplier change requests to determine part re-qualification needs;
Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection;
Request Supplier Corrective Action plan from supplier, based on negative-trending issues from monthly quality data reports. This will include working jointly with the supplier for improvement, resolution and the verification of effectiveness of corrective actions undertaken;
Communicates product specs during the supplier qualification process to suppliers and assesses supplier’s ability to meet Eng. and Quality requirements;
Active member of Change Control team when the proposed change affects suppliers by ensuring timely communication to the supplier takes place and is integrated at the supplier’s facility:
Develop positive relationships and work closely with sourcing leaders to manage, implement and track supplier/engineering, design changes, capacity studies and new product introductions, and transfers;
Develops team culture to provide an optimum environment for employees’ growth and contribution;
Work with Quality, Regulatory and Supply Chain Managers to develop and prioritize a supplier audit schedule to ensure that designated suppliers are audited on a regular basis;
Perform supplier audits, qualifications and re qualifications;
Maintain up-to-date supplier and distributor qualification documents, including quality agreements;
Assist in strategic development of suppliers to support supply chain strategies;
Works directly with suppliers to ensure proper root cause investigations and mitigation activities are completed in a timely manner and are effective;
Improve externally-provided products through implementation of quality management policies, statistical tools, specifications, test methods and measurement systems throughout the supply chain;
Provide direction to suppliers in implementing Incoming Inspection Plans, First Article Inspection, In-Process and Final Product Inspection, FMEAs, Sampling Plans, inspection and test acceptance criteria, and handling non-conformances/CAPA.
Coordinate investigations with suppliers regarding customer complaints received on the supplier’s products;

Act as liaison between supplier, quality engineers, Regulatory, Operations, and Supply Chain when issues associated with rejected goods, customer complaints, or other non-conformities are realized so that improvements and corrective actions can be implemented and monitored;
Develop and implement programs to improve supplier performance;
Prepares monthly data related to supplier quality for SCAR, supplier scorecard evaluation;
Use engineering expertise to increase supplier quality reliability, and conduct capability assessments as needed;
Implements key quality metrics, measures and communicates annual performance with both supplier’s and quality manager(s) so that the ongoing performance of the supplier can be understood, and continuous improvement plans implemented as needed;
Execute as needed, jointly with supplier, continuous improvement programs such as SPC, DOE, PFMEA, Gage R&R, and Control Plans;
Participate in engineering change order activities, material review boards, and change control as required to support program performance;
Establish specific short/long term supplier quality goals;
Ensure maintenance of up-to-date supplier agreements with all suppliers;
Serves as Subject Matter Expert (SME) for the SCAR process and ensure the SCAR process remains compliant with Quality System, corporate and regulatory guidelines and functions at optimal business and customer service levels;
Monitors and reports monthly on the effectivity of open SCARs;
Works cross functionally to ensure a team-based approach for an effective SCAR with emphasis on effective root cause analysis of issues;
Ensures effective use of problem-solving tools such as fishbone, 6M, 8D etc.;
Ensures that all SCARs have complete and effective investigations, root cause analysis, and action plans;
Review and approve investigating plan and corrective and preventative action plans;
Ensures that the implementation of SCARs is effective, timely, and suitably closed out;
Analyze and organize data from multiple sources by utilizing statistical and data analysis tools to identify trends and recommend updates or changes when necessary;
Assists in the coordination of the internal audit program and activities, including establish internal audit schedule and ensure timely completion of internal audits;
Mentors, coaches internal auditors and provides internal audit training activities;
Ensure internal audits reports are complete and accurate;
Develop and revise all applicable standard operational procedures, work instructions, forms etc. to meet corporate, regulatory and ISO requirements and optimize the quality management system;
Documents quality data using good documentation practices both manually and electronically, ensuring all quality data is in a retrievable state to support continuous improvement activities;
Communicates quality related problems to management, and other necessary parties, fostering timely resolution and improvement; and
Other duties as directed and/or approved by the QA Manager.

BACKGROUND and SKILLS: Educational Qualifications:

Bachelor’s degree in a scientific discipline
Certified Supplier Quality Manager Certification and/or Certified Quality System Auditor is a plus

Job Requirements:
Required Knowledge, Skills, and Abilities:

5+ years of manufacturing, quality assurance, and/or engineering experience preferred;
Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) is preferred;
Working knowledge of standard quality system requirements (ISO 13485, Medical Device Directive, Canadian Medical Device Regulation, MDSAP) preferred;
Prior experience as an internal auditor required;
Supplier quality experience in medical device or related GMP environment preferred;
Strong process validation knowledge and background;
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate quality risks;
Strong problem-solving skills and ability to make firm decisions;
Highly motivated self-starter with the ability to function in a fast paced team oriented environment with minimal supervision;
Must have excellent problem solving, time management, organizational, and interpersonal skills, with the ability to work independently;
Ability to deal with a variety of variables in situations where limited information exists;
Ability to manage conflict;
Excellent communication and influence skills with the ability to work interactively with off-site resources;
Ability to articulate thoughts and ideas effectively through both written and oral communication;
Proficient in Microsoft Office software, including Outlook, Word, Excel, and PowerPoint, as applicable;
Microsoft Dynamics AX knowledge preferred;
Ability to perform effective investigational and root cause activities;
Ability to multitask and prioritize projects to meet defined timeliness requirements;
Must be detailed oriented and well organized

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel: None
Vacation Time: 2 weeks / year

Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Relocation Assistance, Casual Dress

Contact Information:
Contact Name: Max Sabrin Company Type: Recruiter
Company: EIR Network
City: Old Saybrook
State: Connecticut
Zip: 06475
Web Site:

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