Johnson & Johnson Careers
Senior Compliance Specialist
Requisition ID: 1805681742W
Our site in Zuchwil is looking for a talented Senior Compliance Specialist!
1. Overall responsibilities
The Senior Compliance Specialist, DePuy Synthes ensures effective business wide compliance
program that meets requirements for the medical device business. This position will partner with
Compliance leaders globally to ensure audit readiness and overall compliance. This individual will
collaborate with all levels building partnerships to further DePuy Synthes in the refinement of short
and long term compliance objectives. This position is a part of the Regulatory Compliance team of
DePuySynthes. This role provides Quality System Compliance support to the assigned site(s).
This includes the procedures and records required for the development, deployment and
maintainence of quality system processes in order to assure the ongoing compliance with ISO13485,
FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.
2. Position duties and responsibilities
- Responsible for ensuring compliance of local implementation of Quality System with all local,
national, international and company regulations, policies and procedures.
- Ensures that all activities are carried out in compliance with all applicable regulations, policies and
procedures governing business and quality operations.
- Ensures all assigned quality actions, and all internal and external audit observations, are investigated, have causes identified actions plans completed, and appropriate effectiveness
monitoring performed to the agreed schedule, regardless of source.
- Drive Compliance improvements, which result from internal audits, Quality Board Issues and other
- Support other areas of the business as required e.g. Data Management/ DHR review/complaint
- Work effectively with the other site compliance engineers/ specialist to ensure consistent systems.
- Keep up to date with all new legislation and regulation standards for applicable all countries and
ensure compliance to any changes to these across the facility.
- Represent DePuySynthes to create tools to prepare sites for external audit and also a tool assess the
Compliance Status of the site
- Implement harmonized J&J and MD&D Compliance Standards and SOPs
- Generate such data as is required for Dashboard reviews; Act as site EtQ Audit module support
- Creation, deployment and Maintenance of the internal audit schedule
- Perform required audits in accordance with defined procedures and the master schedule; identify
and perform “for cause” audits.
- Ensure proper internal audit reporting, response review and approvals, communication of issues,
and use of tracking and trending tools.
- Coach and guide Quality System Auditors and support staff as required to ensure appropriate
control systems are in place and continually optimized to meet changing regulatory, corporate and
- Train and maintain users on the Audit system.
- Provide Front Room/ Back Room support during external audits
- Establish and maintain regulatory inspection readiness plans for assigned sites.
- Co Host external audits and assessments that take place on DePuySynthes site and serve as the
representative for the Internal Audit program
- If required assist other facilities for both external audit prep and assistance during their external
- At least Bachelor degree in Science, Engineering, Quality or other technical field
- Equivalent degree and/or adequate associated work experience is acceptable
- Lead Auditor qualification is required
- Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment.
- At least 6 to 8 years working experience in a regulated industy
- At least 3 years experience in a quality and/or compliance function
- Experience in performing audits is required
- Experience in internaction with Health Authorities and Notified Bodies is required
Interpersonal skills / characteristics:
- High Attention to Detail
- Ability to make complex issues simple
- Excellent Communication Skills (written & oral)
- Team Player
- Excellent time management
- Focus on achievement and delivery of results
- Active Listener
- Available to travel
- Fluent German, fluent English
Synthes GmbH (7111)