Quality Systems Regulatory Engineer

Helmer Scientific designs, integrates, manufactures, markets, and distributes specialized medical and laboratory equipment to clinical and life science customers in over 125 countries.
At Helmer:

• We offer competitive salary and benefits
• We offer a positive team environment
• We offer an opportunity to fulfill potential by performing meaningful and rewarding work
• We are committed to serving customers, team members and the world community
  Are you ready to join us and make a difference? We have a career opportunity for a Quality Systems Regulatory Engineer to join our team!
  
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            Responsibilities:
            The Quality Systems/Regulatory Engineer provides objective oversight of product design activities to provide assurance that requirements for customer and market access are fulfilled. The role is also responsible for ensuring Helmer Scientific’s Quality Management System remains compliant with applicable standards, regulations and directives.

            Primary responsibilities include:
            

            • Promotes Helmer values as demonstrated in personal productivity and quality of work, management of internal/external relationships, actively seeking out and participating in Continuous Improvement practices, and willingness to engage and support team initiatives.
            • Promote a safe work environment. Enforce and comply with workplace safety procedures for self and Quality team.

            Product Quality and Compliance

            • Provides quality and regulatory oversite and consulting for new product development and design changes. Ensures design documentation meets quality system and regulatory requirements.
            • Provides objective review of risk management and verification and validation activities.
            • Participates in customer experience review activities including but not limited to analysis of technical service and customer complaint data for trends requiring escalation to the CAPA process and or feedback to design teams. Participates in complaint review. May review technical service and complaint data, including identification, escalation, handling, and closure of complaints-related activities.
            • Coordinates and or fulfils regulatory documentation needs for country registrations through i nterpretation of standards and regulations as well as through the use of outside services/consultants.

            Quality System Compliance
            

            • Responsible for the implementation and continuous improvement of the internal audit program including scheduling, planning, auditor training, audit execution, post-audit follow-up, and corrective action initiation and or recommendation for improvement.
            • Oversees the document and change control system including leadership of the Document Control Administrator. Responsible for providing guidance on daily basis. Tracks and monitors attendance, performance and growth plan. Provides on-going feedback and coaching. Is responsible for approving PTO requests, takes appropriate action to address performance and conduct issues, addresses employee complaints/concerns and resolves problems.
            • Identifies and implements improvements or regulation driven changes to Quality System processes and procedures. Teams with the Director of Quality and Regulatory in customer and third party audits. Coordinates and responds to nonconformances from customer and third party audits and ensures effective implementation of corrective action plans.
            • Administrates and improves the corrective and preventative action (CAPA) process. Assists functional leaders with development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results.
            • Provides quality system training for new employees and other duties as assigned.

            Qualifications:
            Relative Work Experience :

            • Minimum 8 years work experience in medical device or related regulated industry; including prior quality systems experience and leading internal audits.
            • A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, complaint handling and post-market surveillance.
            • An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
            • Project management and Lean and/or Six Sigma experience a plus.
            • Familiarity with DFMEA and reliability test planning.

            Education: BS degree in Engineering or related discipline.

            Certifications / Licenses : CQA and CQE preferred but not required.

            Computer Systems / Software : Proficient in Microsoft Office Suite.

            Key Competencies :

            • Ability to balance interests of a variety of customers; readily readjusts priorities to respond to pressing and changing demands.
            • Ability to secure relevant information in identifying key issues and relationship from a base of information; relay and compare data from different sources; identify cause-effect relationships and recommend viable solutions.
            • Ability to develop procedures and training materials using applicable software tools (Microsoft Word, PowerPoint, Visio).
            • Excellent verbal communication skills, including the ability to communicate to all levels of an organization.
            • Strong analytical and problem solving skills, including the ability to identify and implement novel solutions to meet business needs. Ability to work both independently and in partnership with others.
            • Strong organization and project management skills.
            • Demonstrated ability to collaborate with cross functional teams while assurance compliance.

            As an EEO/AA Employer all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, ancestry, disability status, sexual orientation, gender identity, genetic information, veteran status or any other protected characteristic.