Hill-Rom Product Quality Engineer in Batesville, Indiana
The Product Quality Engineer is responsible for supporting the quality and regulatory related matters associated with the medical bed devices at the Hill-Rom Batesville Manufacturing site. This position will also be responsible overseeing and/or assisting with a variety of Quality Engineering functions and ensuring compliance with QSR regulations and Hill-Rom policies and procedures. In addition, this position will work to provide the necessary data to make effective quality and business decisions, and implement sound, data-driven quality and business solutions that emphasize quality system compliance. The Product Quality Engineer will need to maintain a teamwork approach to all tasks and nurture professional relationships with other departments and outside agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:
Serve as a primary point of contact for quality & regulatory related matters associated with support for medical bed devices.
Drive quality system improvements and ensure compliance to regulatory and procedural requirements.
Responsible for leading quality initiatives with operations to improve manufacturing processes and product quality.
Interface with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.
Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection.
Interface with Supplier’s engineering and Quality organizations to efficiently resolve quality issue via VQN and SCN’s.
Support operations in trouble-shooting non-conformities to confirm part defects.
Participate in external and internal regulatory compliance inspections.
Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ).
Participate in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.
Lead the Health Hazard Evaluation activities for the assigned areas
Ensure appropriate controls (key metrics) are defined, implemented and satisfactorily completed for all appropriate operations.
Ensure accurate and timely processing of all Quality Records along with the company’s regulatory compliance profile per 21CFR820 regulations.
Collect, analyze and track key data across the Batesville manufacturing site related to entity quality and to monitor and to monitor key performance indicators by interfacing with key partners across the corporation.
Provide training to ensure proper implementation and use of quality tools and procedures as required.
Enable rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.
Review/approve nonconforming materials and associated documentation.
Review/approve product and process change control documentation and specifications.
Use quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).
Investigate product quality problems, determine root cause, gather and analyze data and implement corrective action to reduce or eliminate cause
Work closely with Operations to Identify and resolve production and quality system deficiencies
Participate in the improvement of the manufacturing process for existing products. Review and approve work instructions, inspection documents, Bills of Material and drawings.
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
Proficient with Quality System Regulations, Medical Device Directive, and ISO Quality System Standards
Strong understanding of ISO 13485;
Demonstrated ability to work and perform in team environments and effective interpersonal skills
Demonstrated high attention to detail
Excellent analytical decision making and problem solving skills
Proven ability to resolve issues and participate in process improvement activities
Track record of successful business and customer orientation
Excellent written and verbal communication skills
Ability to define problems, collect data, establish facts and draw conclusions
Ability to effectively present information in one-on-one and small group situations
Primary Location: United States-Indiana-Batesville
Posting Entity Hillrom
Req ID: 19124951