In this role, the Quality Compliance Engineering Manager leads a team of Quality Specialists who are responsible for the feedback system in the QMS- customer complaints handling, complaints trending, RMA and returned goods, issuing corrections and corrective actions related to complaints and Quality reports. The Quality Compliance Engineering Manager also leads the sites external audit program, preparedness, and execution by any third party, customer, applicable regulatory authorities (including Notified Body), while working within a multi-functional team environment for medical devices. As a part of the preparedness for external audits, the Quality Compliance Engineering Manager ensures that all applicable activities done by all company employees meet applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting applicable regulatory requirements. The Quality Compliance Engineering Manager also leads the supplier quality management system, audits, Quality agreements, SCAR, etc.
The Quality Compliance Engineering Manager will be a strong advocate for quality, supporting the sites abilities to meet all applicable and current versions of the Quality and Regulatory requirements, such as EN ISO/ISO 13485, Medical Device Regulation (MDR) 2017/745 and MDD 93/42/EEC, MDSAP, ISO 14971.
The Quality Compliance Engineering Manager supports continuance improvement of the QMS, site procedures alignment with applicable Regulatory requirements, alignment with the Enterprise Quality System and provides guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards for us and its subcontractors. The Quality Compliance Engineering Manager will lead a team executing the QMS related transactions in relevant GMP systems (MasterControl,SAP, Share Point) and other relevant quality functions, as applicable.
Requirements: Basic Qualifications:
B.Sc. - Chemistry/ Biology/ Eng. an advantage.
Minimum 8 years working in quality systems in the Medical Device industry.
Relevant work history and/or experience may be considered in lieu of degree.
Experience with customer interface and meeting customer expectations.
Experience Risk Based Approach, Root Cause Analysis, Customer complaints, CAPA, Internal Audit.
Experience with writing and reviewing Quality agreements- Advantage.
Proven experience with ISO 13485, MDSAP and CE audits- Advantage.
Excellent written and oral communication skills.
Excellent critical reading and writing skills.
Must have effective problem solving and interpersonal skills.
Ability to work independently, multi-task and thrive in fast-paced environment.
Problem solving including root cause failure analysis methods.
Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
Able to comply with the companys safety policy at all times.
Preferred Knowledge, languages, Skills and Abilities:
Courses on topics related to quality system/regulatory requirements in the medical device.
Proven knowledge with ISO 13485, MDSAP, and MDR 2017/745.
English- high level in both verbal and written.
Certified Quality Auditor.
Adaptable to changes in the work environment, manage QA personnel in competing demands and deal with frequent change, delays or unexpected events.
Must be able to multi-task, work under time constraints, problem solve, and prioritize.
Ability to make independent and sound judgments.
Observe and interpret situations, analyze and provide guidance in different teams problems solving.
Effectively communicate and interface with various levels internally and lead the QA personnel for success.
Manage at least 2 Quality Specialists/engineers.
This position is open to all candidates.
