What are the responsibilities and job description for the Senior Quality Engineer position at Röchling Medical?
The Rochester location is Röchling Medical's center of excellence for the production of surgical forceps for minimally invasive electrosurgical devices and also offers a broad portfolio of plastic injection molded parts and value-added assembly work for the medical industry. With its technical expertise, the team in Rochester is able to support customers as a contract manufacturer for the entire product lifecycle from concept to complete approved medical device.
Job Summary:
The Sr. Quality Engineer is responsible for leading quality engineering activities that ensure products, manufacturing processes, and quality systems meet all applicable regulatory, customer, and company requirements. This role provides technical leadership for quality initiatives, supports new product development and validation, drives continuous improvement efforts, and partners cross-functionally to improve product quality and manufacturing performance.
Responsible lead for:
- Major quality system improvement projects, CAPA SME
- SME / Coach of specific Quality Processes (Document control, Change Control, Training, Validation)
- Major customer complaints
- Audit SME
Essential Duties/Responsibilities:
- Manage and Support Complaints, and CAPAs using Problem Solving & Root-cause Analysis Tools:
- 5-why Analysis
- Fishbone Analysis
- Scheduling Brainstorm sessions
- Documenting Continuous Improvement Activities
- Tracing production history throughout ERP, and other systems
- Support Audits
- Internal Auditor
- Subject Matter Expert during external audits
- Front and Back Room support during customer and process audits
- Perform supplier audits, support qualification of new suppliers
- Lead process audits
- Monitor and analyze quality performance and present metrics
- Drive Quality System improvement projects
- Write and revise Forms, Work Instructions and SOP’s
- Manage implementation and related change orders
- Train others on process changes
- Support Engineering Development and Validation activities.
- Process validation
- Software validation
- Communicate directly with customers throughout
- Project meetings
- Quality issues
Required Skills/Abilities:
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills and attention to detail.
- Strong understanding of FDA (21 CFR Part 820/QMSR), and ISO 13485 Quality System
- Strong analytical and problem-solving skills.
- Strong leadership skills.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to function well in a high-paced and at times stressful environment.
- Ability to simplify complex situations and present them with an appropriate level of detail
- Ability to analyze risk and make decisions
- Proficient with statistical software
- Ability to travel as required to Suppliers, Customers, and other events. Up to 10%
Education and Experience:
Required
- Bachelor’s degree in engineering, Quality, Manufacturing, or related technical discipline.
- 8 years of Quality Engineering experience in a regulated manufacturing environment.
Preferred
- ASQ Certified Quality Engineer (CQE).
- Lean Six Sigma Black Belt certification.
Roechling Medical Rochester is an Equal Opportunity Employer. RMR does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Salary : $105,000 - $125,000