Quality & Compliance Engineer- Humacao, PR - 092310
Johnson Controls is a global diversified technology and industrial leader serving customers in more than 150 countries. Our 162,000 employees create quality products, services and solutions to optimize energy and operational efficiencies of buildings; lead-acid automotive batteries and advanced batteries for hybrid and electric vehicles; and interior systems for automobiles. Our commitment to sustainability dates back to our roots in 1885, with the invention of the first electric room thermostat. Through our growth strategies and by increasing market share we are committed to delivering value to shareholders and making our customers successful. In 2011, Corporate Responsibility Magazine recognized Johnson Controls as the #1 company in its annual "100 Best Corporate Citizens" list. For additional information, please visit http://www.johnsoncontrols.com. JCI is an Equal Opportunity/Affirmative Action employer, and as such does not discriminate in its recruiting and selection process based on disability or handicap status. If you are a person with a disability and you need an accommodation during the application process, please call our Talent Acquisition Hotline at (414)-524-8999 and press option #0.
Under minimal supervision, assists with audits on and reviews Johnson Controls (JCI) and subcontractor/vendor operations and documentation for compliance with local and global regulatory standards. Must have a good understanding of Quality Systems & Compliance within a Life Science Environment. Serves as a Quality Assurance (QA) resource to support documentation and other compliance related activities. Help to coordinate implementation of best practices tasks across departments, sites and regions as directed.
Assist with audits of company and subcontractor operations and documentation to ensure compliance with customer identified regulatory requirements, JCI policies/procedures and contractual requirements. Documents and reports audit observations to Quality Management.
Interface between customer regulatory/compliance personnel and JCI operations to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements.
Assist with compliance related activities and documentation. Such activities include, but are not limited to: compiling and analyzing data, creating reports, creating/reviewing change requests, reviewing executed documentation and coordination between JCI, subcontractors and the customer on compliance related activities.
Coordinates implementation of process/work flow tasks for both JCI and the customer as it relates to compliance related operations.
Participates in internal customer and external regulatory quality assurance audits as directed by Quality Management. Assists with follow-ups regarding identified audit issues.
Review data and documentation on a routine basis or as requested.
Assists in development, implementation and maintenance of new procedures governing compliance related operations.
Generate compliance and performance reports for monthly metrics or as requested by the customer.
Monitor personnel activities for quality and compliance matters.
Complies with all company policies and procedures, and adheres to company standards.
Performs other duties as requested.
Bachelor’s degree in engineering or applied science preferred.
Broad experience with quality systems required, investigations and CAPA
Prior experience in a regulated environment such as the pharmaceutical, medical device or other life science industry preferred.
Specialized training or certification in quality assurance audits preferred.
Experience with Microsoft Word and Excel. Database and reporting experience preferred.
Excellent interpersonal and communication skills to effectively work with management and employees at all levels within an organization, including customers.
Willing to travel to support multi-site operations and audits.
Able to work varying shifts, including weekends and holidays as needed.
Must have demonstrated experience in a safe, team-based, high-performance, quality-driven environment.
Johnson Controls, Inc. (Johnson Controls) provides automotive interiors, products and services that optimize energy usage in buildings and...