US, York, SC Assistant Quality Manager 2022-53
We have an exciting new position created in response to the growth of our business for an Assistant Quality Manager for our recently established Elkem Silicones Advanced Specialties (ESAS) manufacturing location for someone with working knowledge of ISO 13485 and related topics.
This role is responsible for providing oversight to all functions in developing and maintaining good Manufacturing Practices (GMP)/ Good Documentation Practices (GDP) and ensuring Quality Management System compliance with practices in support of our long term implantable silicones product line. This includes maintaining ESAS site compliance by adherence to SOPs, policies, and the overall Quality Management System requirements, monitoring, measuring, and reporting KPIs, progress against internal goals and corrective action progress/closure.
This is a complex and highly technical role that requires professional judgement in managing unplanned/ambiguous situations outside the typical scope of the Quality Management System. This includes the ability to influence other functions in the implementation of quality and regulatory requirements.
The ESAS Assistant Quality Manager shall provide direct support for customer/regulatory compliance issues, audits, surveys, and product related concerns. The position shall also ensure that external provider qualification activities and assessments are current, reviewed and approved. This role is also responsible for reviewing and approving Management of Change requests impacting products/processes at ESAS, and that the ESAS/York Service Agreement is effectively implemented.
Problem solving will include challenges that are internal and external in nature. As the ESAS site management representative this role will have to negotiate the closure of regulatory and internal/external audit findings with regular status updates for the top management team. Problem solving skills requires in-depth knowledge of 8D, 5-Why, Cause and Effect Diagraming, and other advance techniques.
There are two positions that will be reporting to this position; a quality engineer and a document control specialist. Indirectly, this position must be able to lead, collaborate with and influence other functions to ensure that they are completing the necessary actions in order for us to remain in compliance with customer and regulatory requirements.
- Bachelor’s degree in appropriate science (quality, math, statistics, chemistry, or engineering) required.
- Must have a minimum of 5 years of medical device or pharmaceutical experience specifically in a quality function.
- Management or leadership experience is required.
- High degree of attention to detail.
- Function as the management representative for regulated markets as defined in the site Quality Management Systems
- Knowledge of or certification in Biomedical Quality Management Systems
- Desire prior experience in the applicable parts of FDA 21 CFR, ISO 9001, ISO 13485, quality systems that include: IQ/OQ/PQ Validations, FMEA (Failure Mode Effects Analysis), MSA (Measurement Systems Analysis), change management, document control, and Statistical Process Control (SPC).
- Knowledge of, or certification for Lean Six Sigma Black Belt or similar techniques.
- Strong verbal and written communication skills to communicate with all levels of the organization.
- Ability to analyze/synthesize complex or diverse information, present recommendations and resolve problems effectively.
- Able to impact and influence others without relying on formal authority.
- Strong interpersonal, team and customer relationship building skills.
- Knowledgeable of various computer-based systems.
- Must be organized, have proven planning and control skills.
- Able to travel in support of supplier audit and qualification activities.
Elkem will conduct a post-offer background check to confirm the information provided by candidates during the recruitment process. Additionally, a post-offer physical, including a substance screening, is required. Relevant candidates will be informed of this if it applies.
We are an Equal Opportunity Employer – M/F/Veteran/Disabled and if you are an individual with a disability, who requires an accommodation, please contact us.
- Region: North America
- Division: Silicones
- Job type: Quality
- Working hours: Full Time
- Working days:
- Application deadline: 30.09.2022
- Location: York, SC