Compliance & Audit Manager
The Compliance Manager is both the primary global compliance manager and the primary corporate site compliance manager. He/she is responsible for strategic and tactical planning, for ensuring that all products being developed and being produced is compliant with internal product specifications, meets all customer requirements, and is compliant with all regulatory and 3rd party certifications, regulations, and policies.
Note: Some travel may be required in this position. Estimated no more than 10 to 20%.
- Stay abreast with changes to regulatory, environmental and customer requirements along with recommending actions required to maintain compliance and communicate any changes to the global organization.
- Ensure implementation and compliance of all and regulatory policies and practices.
- Make sure all manufactured products maintain regulatory certifications. (IEC, NEC, UL, NOM, CSA, etc.)
- Act as point of contact and subject matter expert for R&D regulations and compliance internally and externally. Collect knowledge on various product regulations for use in customer interactions and internal knowledge sharing.
- Other projects and tasks as assigned by Quality Management team and/or as dictated by needs of the business and approved by Site Quality Leader.
- Prevent compliance issues by collaborating with the engineering and the product development teams
- Collaborate with other global sites and QMS or compliance personnel
- Develop and maintain the QMS system to comply with ISO 9001, ISO 13485, FDA 21 CFR Part 11, and other standards on a site-by-site, region-by-region basis.
- Training the workforce on daily compliance to processes and procedures and the importance of following the standards
- Perform compliance reviews, as part of NPI, including safety, regulatory, environmental compliance (RoHS, REACH, Conflict Minerals) and risk assessment of potential sources of supply.
- Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.
- Review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer to manufacturing and suppliers.
- BS/ MS in Electrical Engineering or relevant experience
- ISO9000 & 14001 experience
- FDA regulatory experience / ISO13485 experience a plus
- 6 to 8 years previous experience working in regulatory compliance roles within electronics manufacturing, R&D, or related industry.
- Previous experience working directly with certification and regulatory agencies is preferred
- Self-starter mentality with the ability to confidently work independently.
- Previous working experience with compliance in both domestic and international markets is preferred.
- Outstanding project management skills
- Ability to work in a fast paced and demanding atmosphere
- Excellent communication skills both written and verbal
- Attention to Detail
- Ability to work independently and exercise sound judgment and discretion
- Project Management Skills
- Previous Global Experience
- Strong organizational and time management skills
- Proficient in Word, Excel, Project, Power Point, Minitab, as well as hardware and software tools to accomplish day to day work activities
Machinery operation requires the use of safety equipment to include but not limited to; eye safety glasses, hearing protectors, work boots and hardhats. Loose fitting clothes and jewelry are not permitted.