Sr. Engineer QA Validation

Exactech, Inc.
Job Description

Job Details

Description

Duties and Responsibilities (Key Deliverables):
1. Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports.
2. Executes activities related to the compliance of the sterility assurance program (e.g. Biocompatibility/Endotoxin testing and quarterly dose audits).
3. Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies.
4. Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements.
5. Use statistical techniques, as necessary, to properly design and execute V&V activities.
6. Prepare documentation and execute V&V activities utilizing a risk based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
7. Coordinate personnel training, protocol and process documentation/record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.
8. Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
9. Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings.
10. Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards.
11. Identify, analyze and correct internal and external manufacturing deviations and/or anomalies related to V&V activities ensuring optimization of production processes.
12. Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation.
13. Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase.
14. Informs Regulatory Affairs of validation projects that may require further reporting/scrutiny (e.g. PMA devices).
15. Participate in the review and qualification of external supply chain V&V activities.
16. Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions.
17. Define and lead third party, customer and regulatory audits as they pertain to validations.
18. Know and apply the Quality System and any appropriate Federal and International standards
19. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:
Education: Bachelor’s Degree from an accredited institution required; Master’s Degree preferred
Experience:
• Minimum 7 years experience in the medical device industry
• Advanced level of technical software proficiency
• Excellent Quality System knowledge required
• Strong time management and project management skills are necessary.
• Experience writing IQ/OQ/PQ V&V protocols.
• Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.
• General understanding of sterilization and related analytical testing is a plus.
• Must be able to work independently and in a team environment.

Functional/Technical Knowledge, Skills and Abilities Required:
• Statistical expertise in areas such as process capability, process assurance and sampling
• Expertise in Microsoft Office products
• Ability to work effectively in a team environment
• ASQ Certifications preferred
• Advanced level of technical software proficiency.
• Working knowledge of statistical analysis and sampling plans.
• Excellent communication (written and verbal) skills.
• Excellent organization skills.

Competencies: To be completed by Human Resources.

Core:
Work Standards Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Decision Making Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
Managing Work (includes Time Management) Effectively managing one's time and resources to ensure that work is completed efficiently.
Planning and Organizing Establishing courses of action for self and others to ensure that work is completed efficiently.
Building Strategic Work Relationships Developing and using collaborative relationships to facilitate the accomplishment of work goals.
Energy Consistently maintaining high levels of activity or productivity; operating with vigor, effectiveness, and determination over extended periods of time.

Functional:
Statistical Application Understands how to apply statistical methods; knowledge of product sampling
Document Change Process Capability Can generate document change requests and various charts/graphs by using company operating software such as Team Center/MFG Pro

Physical Requirements:
Type ONE ‘X’ for each Activity to indicate the appropriate Physical Requirements:
ACTIVITIES ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS

Mobility

  • Frequent sitting
  • Limited standing, walking, climbing, crouching, bending, pushing, or pulling X
  • Occasional sitting
  • Occasional standing, walking, climbing, crouching, bending, pushing, or pulling
  • Limited sitting
  • Frequent standing, walking, climbing, crouching, bending, pushing, or pulling

Travel X

  • Limited travel or overnight
  • Occasional travel or overnight
  • Frequent travel or overnight; including international

Visual/Hearing X

  • Normal or corrected vision and hearing
  • Normal or corrected vision and hearing
  • Not colorblind
  • Normal or corrected vision and hearing
  • Not colorblind
  • Can distinguish varying or specific colors, patterns or materials

Language

  • Understand, speak, read and write basic English X
  • Understand, speak, read, and write fluent English
  • Understand, speak, read and write fluent English
  • Understand, speak, read and write fluently in a foreign language

Physical Activity X

  • Lift approximately 0-25 lbs.
  • Use of fine motor hand functions
  • Lift approximately 25-50 lbs.
  • Use of fine motor hand functions
  • Lift approximately 50+ lbs.
  • Use of fine motor hand functions

Environment X

  • Typically indoors
  • Typically in a consistent temperature
  • Occasionally outdoors
  • Occasionally exposed to varying degrees of hot and cold environments
  • Frequently outdoors
  • Frequently exposed to varying temperatures from below 32 degrees to above 80 degrees

Operating Room Entry X

  • Typically in office environment without a need to enter the OR
  • Infrequent entry to the OR. No credentialing required. 
  • Frequent entry to the OR. Must be able to clear all credentialing and vaccination requirements

Valid Driver’s License X

  • Required for position
  • Helpful but not required ? Not required


Environmental Considerations:
Type ONE ‘X’ for each Activity to indicate the appropriate Environmental Considerations:
ACTIVITIES ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS ESSENTIAL FUNCTIONS

Safety X

  • Typically not in a manufacturing environment, no special safety considerations
  • Typical manufacturing environment
  • Safety glasses required
  • Typical manufacturing environment
  • Safety glasses required
  • Steel Toed shoes required

Blood borne Pathogens X

  • No risk of exposure
  • Limited risk of exposure to blood borne pathogens
  • Likely exposure to blood borne pathogens

Chemical X

  • No risk of exposure
  • Limited risk of exposure to hazardous chemicals
  • Exposure to hazardous chemicals


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)

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