Quality Process Manager

Exton, PA

The Process Quality Manager leads and owns initiatives within the Quality department, while working cross-functionally on product testing and quality process improvements for synergy and compliance to the quality system as well as the current specifications for each product line. These activites can include but are not limited to leading quality process improvements, leading the identification and execution of testing reduction initiatives, ownership of quality processes (calibration, out of specifcaition, certification of product, non-conforming product material management etc.), lead non-conformance investigations related to quality control, establishment and monitoring or statistical process control within production, scheduling running business DOE/experimental testing and ensuring training of quality personnel as required. This role will also guide technical specialists on the execution of ECR/ECO documentation changes to implement updates to any of the above mentioned activities.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

Key Responsibilities:

• Manage the release of Quality records and issuance of Certificate of Conformances.

• Ensure accuracy and completeness of reports and Quality documentation including calibration.

• Supervise site contamination control

• Supervise test method reduction initiatives

• Supervise out of specification and non-conformance investigations related to quality control

• Establish and maintain program for statistical process control

• Maintain ownership of quality process compliance and establish effective training programs

• Supervise implementation of quality process improvements

• Schedule and supervise Running Business DOE and investigational testing

• Develop, implement and supervise an efficient team, working processes and systems, in order to enable optimal Quality performance

• Develop and maintain a culture of teamwork to motivate and develop staff and foster harmonious relations across all disciplines.

• Meet with direct reports individually to provide regular performance feedback, develop subordinates' skills, and encourage growth.

• Supervise and improve the skills of the staff.

• Recommend and provide training requirements to keep the staff at the highest level of skill necessary to meet the established requirements.

  We Bring:

• A competitive compensation package, with comprehensive health and welfare benefits.

• A place to grow and develop.

• A company that is purpose-led and performance-driven in a corporate culture that values people and planet.

• The opportunity to work on growing brands and build on a strong foundation.

• The chance to make improvements and make an impact on the business.

  You Bring:

• Bachelor of Science (B.S.) degree in IT, Scientific or technical field.

• Minimum of 5 years progressive experience in QA Systems, preferably in Medical Device Manufacturing.

• Extensive experience with quality processes and systems in a regulated quality environment.

• Extensive experience with management systems, preferably in the area of quality (ISO 9001, ISO 13485, cGMP).

• Experience in generating long term plans and policy plans.

• Knowledge of and experience in the regulatory/quality area of medical devices (ISO 13485, MDD, 21 CFR 820).

• Knowledge of validation and statistical methods; knowledge of other quality relevant global regulations.

• Excellent knowledge of management systems, including management of changes.

  dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there’s a place for everyone at dsm-firmenich.

  As a committed equal opportunity employer, we ensure our recruitment practices are inclusive and fair.We encourage the recruitment of a diverse workforce, representative of the communities in which we work, by using inclusive language, diverse interview panels, diversified sourcing strategies. Selection is based on qualifications, competency, experience, performance history and fit with the team to advance fair and equitable opportunity.

  Employment decisions are based upon job-related reasons regardless of an applicant'srace, color, ethnicity, national origin, religion,gender, gender identity or expression, sexual orientation, age, disability, backgrounds, genetic information, protected veteran status, or any other status protected by law.

  We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

  Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency’s fees, percentages or similar.