Senior Engineer Quality Operations

Exactech, Inc.
Job Description

Job Details

Description

Purpose:

The Senior Engineer Quality Operation shall provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.

Duties and Responsibilities (Key Deliverables):

1. Develop and validate statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes, and components. 

2. Analyze, justify, recommend and qualify purchasing of in house or vendor supplied inspection equipment.  

3. Drive disposition non-conforming (NC) product within MRB, coordinating related containment and investigation actions for timely NC closure.

4. Responsible for initiation, support, and file stock audit summary report for commercial hold for potential product escapes.

5. Support execution and analysis of complaints and/or product field actions.

6. Communicate & collaborate with suppliers regarding NC, escalating supplier corrective action requests as required. 

7. Support manufacturing transfer between sites/facilities/suppliers, executing appropriate quality activities.

8. Performs critical assessment of internal and supplier proposed change management activities. 

9. Maintain Key Performance Indicators (KPIs) for monitoring of process, quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

10. Understanding of risk management practices and concepts and applying knowledge to operation.

11. Leads and/or participates in Corrective and Preventive Actions projects.

12. Engage in development and improvement of internal manufacturing processes for existing products.

13. Drive continuous improvement actions to reduce defects and improve process performance.

14. Provide leadership and subject matter expertise in Quality Assurance activities to the overall sites, including but not limited to risk management, process validation, software validation, quality control, design control, statistical methodology, quality inspection sampling plan.

15. Direct or assist inspection training for QC inspectors or QE technicians. 

16. Assist and support cross functional team members as necessary.

17. Knows and apply the Quality System and any appropriate Federal and International standards. 

Job Requirements:

Education: Bachelor’s Degree in a science, engineering or related discipline from an accredited institution required; Master’s Degree preferred

Experience: • Minimum 7 years’ experience or equivalent in highly regulated industry, medical device experience preferred

• Experience in GD&T and use of advanced inspection equipment

• Experience in interaction with regulatory agencies (FDA, BSI, etc.) desired

• Advanced level of technical software proficiency

• Advanced Quality Systems knowledge required

Functional/Technical Knowledge, Skills and Abilities Required:

• ASQ Certified Quality Engineer or equivalent, ASQ Six Sigma Black Belt preferred

• Understanding of US and International Medical Device Regulations

• Familiarity with ISO 13485 required 

• Strong knowledge of Quality body of knowledge (e.g. Risk Management, CAPA, Audits, Statistics).

• Ability to work effectively in a team environment

Qualifications

Education

Required

Bachelors or better.

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Contact Information