Quality Analyst Engineer

POSITION PURPOSE

The Quality Analyst Engineer is responsible for determining production standards for the company’s products by helping to establish quality control systems and setting product requirement rules.

Identifying the specifications for an ideal product, determining an appropriate level of variation and monitoring quality assurance rates.

Helping create solutions as part of an engineering team. They work to find defects, determine the causes of those defects and provide solutions to defected problems.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Supply technical knowledge to a variety of projects within the relevant subject area with minimal assistance.
• Act as a study director, design, and implement method development, validation, and transfer studies including authorship of protocols and reports, by incorporating input from various subject matter experts.
• Collaborate with other functions such as project management, regulatory, extractables, manufacturing and quality in project teams.
• Conduct analytical problem-solving efforts to meet business needs.
• Participate in investigations that correspond to atypical or out-of-specification / out-of-trend results.
• Create, update, and maintain equipment and analytical procedures.
• Appropriately prioritize assignments to meet project schedules. Ability to design experiments and draw meaningful conclusions from lab data in addition to critically review peers’ work.
• Conducting qualitative and quantitative chemical experiments and analyses for research, development, or quality control purposes.
• Interpreting data and adhering to strict guidelines on documentation when recording data.
• Developing and validating new methods for analyzing chemical compounds and substances.
• Operating, maintaining, and troubleshooting complex analytical instruments.
• Using statistical techniques to analyze, interpret, and visualize data.
• Collaborating with chemists and other scientists to conduct research and develop new products.
• Writing technical reports to detail methods, findings, and recommendations.
• Provides Quality insight and leadership on program teams and helps establish appropriate build quality controls commensurate with use.
• Develops and initiates methods for Inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical.
• Develops, documents, and validates inspection and test methods to support design control, in process Inspection, and final inspection activities.
• Participates in the technical review of design input specifications and design documentation for new medical devices.
• Plans, and leads execution of Risk Management on cross functional product development teams. These Items include but are not limited to Risk Management Plans, Preliminary Hazard Analyses, UFMEAs, DFMEAs, PFMEA s, and Risk Management Reports
• Plans, executes, or directs activities concerned with development, application, and maintenance of quality standards as assigned.

Reports results to marketing, manufacturing, process engineering, and product design groups

• Lead, participate in, or coordinate Internal Corrective Action initiatives as assigned.
• Completes component part qualification activities including first articles, cap studies, gage R&R, and implementation of SPC requirements.
• Supports product / process transfers during pilot and manufacturing builds.
• Participate in performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA.
• Support Product / Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.
• Participate on cross-functional teams to develop new products and processes.
• Responsible for initiating pFMEA, Process Flow Diagrams, Process Control Plans, Measurement System Analysis (Gage R&R), Capability Studies, etc.

to ensure compliance to applicable standards (ISO 13485, ISO 17025, ISO 11737, etc.), regulations (21 CFR Part 820, EU MDR, etc.

and internal procedures.

• Work with suppliers to improve product and process quality and assist with correlations studies and inspection plans.
• Execute and support on-time completion of Design Control Deliverables
• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Accountable for Design Verification and Validation planning and execution, including active cross-functional root cause analysis investigation and resolution activities.
• Lead or support Risk Management activities from product Concept through Commercialization
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps.
• Support execution of biocompatibility and sterilization qualifications
• Contribute to implementation of new requirements and compliance with the quality management system.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications;

establishing personal networks; benchmarking state-of-the-art practices.

• Contributes to team effort by accomplishing related results as needed.
• Take on additional Responsibility as directed by management.
• Provide direction to pilot plant operations team to execute experiments.
• Establish process specifications and controls to meet customer and quality requirements.
• Gain expertise in process technology platforms and define manufacturing procedures.
• Lead technology transfer to domestic and global manufacturing plants.
• Pursue continuous improvement and provide ongoing support for safe, efficient, cost-effective, and capable processes.

QUALIFICATIONS

• Bachelor’s degree in science and / or 3 to 5 years of relevant experience.
• Internal Auditor ISO 13485.

KNOWLEDGE & SKILLS

• Knowledge of design of experiments and validation systems.
• Understanding of ISO 13485, GMP, HACCP and USDA and MPI, and DAWR requirements (NZ).
• Problem solving skills.
• Computer literacy and strong skills with Office 365.
• Practical experience in manufacturing or science.
• Ability to work independently and as part of the team.
• Work in a fast-paced environment where accuracy and efficiency are key components.
• Ability to be self-motivated.
• Ability to ensure quality product to our customers.
• Ability to lift and / or carry >

50 lbs. / 22 kgs.Proficiency in English.

INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected.

They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded.

Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions.

In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive.

Additional functions and requirements may be assigned by supervisors as deemed appropriate.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer.

Employees can be terminated for any reason not prohibited by law.