Hr Manager clinical quality & process Jobs – 38 Open Jobs Today

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Senior Design Assurance Quality Engineer II

Hollister Global Business Services India Private L -
Gurugram, Haryana

Apply Now

Job details

Qualifications

Statistics
Six Sigma Certification
SAP
Regulatory reporting
English
Survival analysis
Minitab
Project management
Quality assurance
Bachelor's degree
Product development
Machine learning
Agile
FMEA
Research & development

Full job description

Location- Gurugram

Summary

The Sr. Design Assurance Quality Engineer functions as a project core team member, representing Global Quality and Regulatory Affairs (GQRA) on new product development and change management projects committing to support product/project objectives, driving and participating in business decisions, and assuming accountability for product/project success.

The Sr. Design Assurance Quality Engineer also employs project management methods to serve as an interface between the GQRA extended core team and the project core team leader on new product development projects. The position independently evaluates, selects and applies standard quality techniques, procedures and criteria, using judgment in making decisions on clear and specified objectives, and implements best practice procedures to clarify work processes.

Responsibilities

Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices
Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes
Facilitate design FMEA, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971
Support Specification and Test Method Development, Clinical, Design Verification and Validation
Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes
Utilize parametric and nonparametric statistical analysis methods (including ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, control charts, regression analysis, survival analysis, MSA, acceptance sampling ANSI/ASQ Z1.4 & Z1.9) to ensure products/processes are appropriately characterized and qualified prior to market release
Support review of Preproduction submissions from the Hollister plants and suppliers for new products and significant changes to existing products or processes
Strong knowledge of subject matters related to principles and practices of Quality Engineering
Participate in internal, supplier, and external regulatory agency audits / inspections as required

Essential Functions of the Role

Communicate effectively via email, phone, and virtual platforms.
Collaborate across departments to support organizational goals.
Participate in cross-functional meetings and initiatives.
Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
Prepare reports and dashboards for internal stakeholders.
Ensure data accuracy and confidentiality in compliance with company and legal standards.
Manage multiple priorities and deadlines in a fast-paced environment.
Lead or support special projects aligned with departmental objectives.
Demonstrate initiative in identifying process improvements or automation opportunities.
Serve as a point of contact for internal and external stakeholders.
Resolve inquiries and issues with professionalism and discretion.
Adhere to company policies, including those related to ADA, data privacy, and ethics.
Maintain secure handling of sensitive information.
Support audits and regulatory reporting as needed.

Education & Work Requirements

Bachelor’s Degree with 5-8 years of related experience

Education & Work Preferences

ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer strongly preferred

ASQ Certified Manager of Quality / Operational Excellence or Six Sigma Black Belt certificate is a plus

Background in Quality Engineering and/or New Product Development/R&D
Working Knowledge with Statistics and Statistical Tools (Statistica, Minitab, Excel)
Knowledge of Validation processes and FMEA creation
Professional proficiency in English
Experience with Design Controls and/or product development
Experience with the EU MDD/MDR directives and regulations and ISO 13485 environment at a medical device manufacturer
Project management training and experience
Experience with product development, design controls, and risk management for medical devices (ISO 14971)
Minitab, Stature experience preferred

Competencies

Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.

Location- Gurugram

Apply Now

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