The Quality Engineer Supports Quality with process validations, audits and inspections, corrective/preventive action activities, and Standards Review/gap Analysis. This position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better-quality product more efficiently.
Must be able to commute 5 days a week to facility in Harleysville. PA.
Essential Duties and Responsibilities include the following :
- Responsible for developing and conducting internal process and equipment validations, including IQ, OQ and PQ.
- Review & approve Suppliers process and equipment validations/qualifications (IQ, OQ & PQ).
- Work cross-functionally with Operations and Engineering to establish Process FMEAs to ensure product quality and process performance.
- Establish/Improve Process Validation and PFMEA procedures to ensure regulatory requirements are met.
- Apply statistical methods to ensure reliability of the manufacturing process.
- Participates in Risk Management activities for new and/or modified products and processes which includes risk assessment, authoring risk management plans and reports, facilitating risk assessment activities and approving risk documentation.
- Creates/reviews and approves Quality technical documentation, including purchased materials specifications and change control related documentation.
- Manage and conduct gap analyses for new/revised standard to identify and implement required actions to maintain compliance (State of the Art).
- Lead the execution of initiatives & projects to enhance quality performance and ensure compliance with regulations and standards.
- Provide compliance insights, highlights and supports in continuous improvement opportunities.
- Provide input to Nonconforming & CAPA root cause determination, failure investigations and identification of correction/corrective actions.
- Serves as a core team member for customer audits, ISO audits, and regulatory inspections by attending audits, assisting with document retrieval efforts, and other activities related to audit conduct.
- Work collaboratively with Manufacturing, Engineering, and Supply Planning to achieve strategic initiatives
- Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities.
- Provide training and support for quality system processes and quality engineering practices as needed.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Provide focused quality engineering support and effective coordination and execution of development project activities.
- Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Participate in Material Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyzes customer/internal complaints.
- Performs analytical measurements and experiments to qualify or resolve product and process issues.
- Perform other tasks, as assigned.
Education and/or Experience
- Bachelor's degree from four-year college or university in engineering, life sciences, or similar; or 4 plus years related experience and/or training; or equivalent combination of education and experience. Audit certification and/or auditing experience and lean manufacturing experience preferred is preferred.
- Minimum 4 years engineering experience, with regulated industry experience preferred.
- Audit certification and/or auditing experience and lean manufacturing experience preferred is preferred.
Language Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Manufacturing software; Spreadsheet software and Word Processing software.
Knowledge, Skills & Abilities
- Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803, 806 and European Medical Device Regulation (eMDR), Canadian Medical Device Regulations, ISO 14971, ISO 13485, MDD 93/42/EEC, Software Validation, Process Validation and Test Method Validation.
- Knowledge/understanding of lean manufacturing/six sigma and formal quality processes.
- Experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is required.
- Excellent computer skills
- CAPA, NCRs, Complaints
- Prefer one to two years of auditor experience.
- Communication skills both verbal and written.
- Organizational skills as well as time management skills essential for project work.
- Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.
- Strong writing, mathematics and statistics skill
Our offerings have our Team Members well-being in mind.
- Hybrid schedules available
- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Paid Holidays
- Generous PTO
About Us - Medcomp® develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies.
VISION & MISSION STATEMENT
To be the leading solution provider for every customer we serve.
To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services.
We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed.
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.