Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

About This Role

Develops, establishes and maintains software quality assurance methodologies, systems and practices that meet our client's customer and regulatory requirements. Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused software quality assurance support within new product development, operational or system/services support. Our client values collaboration and synergy. This role follows a hybrid work model requiring employees to be in the local office at least three days per week.

Responsibilities Will Include

• Working within a team of Software Engineers that support embedded R&D systems in the Peripheral Interventions division.
• Actively contributing to all aspects of Software Quality Assurance activities in an FDA-regulated medical device environment and ensuring that software verification and validation is carried out in compliance with site/corporate policies and procedures.
• Performing independent reviews of design, development and testing of software/firmware used in Peripheral Interventions product lines throughout their entire System Development Life Cycle.
• Reviewing and approving documentation associated with qualification, planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix and qualification reports along with support documentation for equipment qualification.
• Reviewing and approving changes to existing systems from a Software QA perspective, ensuring changes are implemented in compliance with internal procedures and external standards.
• Reviewing test results for GDP compliance and ensuring that all test discrepancies to acceptance criteria are adequately controlled, documented and addressed.
• Ensuring that best software QA practices are employed by all departments so that software/firmware-based systems are developed, qualified and maintained in a manner that provides assurance the system conforms to both internal and external requirements.
• Supporting site audits, non-conforming events and CAPAs as required.
• Establish and promote a work environment that supports the Quality Policy and Quality System.
• Establish and cultivate internal business relationships to facilitate task completion and actively participate in project teams.
  
  

Required Qualifications

• Bachelors level degree or higher in Science/Engineering/Software discipline.
• Minimum of 2 years of related work experience in Software QA and/or computer systems validation. -
• Knowledge of the System Development Life Cycle SDLC, preferably with automated manufacturing and computerized lab systems.
  
  

Preferred Qualifications

• Understanding of 21 CFR Part 11 electronic records/electronic signature.
• Experience supporting manufacturing in regulated industry.
• Ability to understand and evaluate procedural documents to ensure compliance with all applicable regulations and requirements.
• Strong organizational skills with the ability to multitask and prioritize competing responsibilities in a fast-paced environment.
• Customer service-oriented with the ability to communicate effectively, written and verbally with individuals at all levels.
• Ability to work independently and collaborate with internal teams.
• Strong problem-solving and critical thinking skills, analytical process and results oriented.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.