Quality Engineer at ARCH Global Precision

Essential Functions

• Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Collaborate with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
• Ensure quality and completeness of project design history files, validation packages, and change orders.
• Provide ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes
• Enhance and drive product risk management activities. Ensure identified activities and mitigations are executed as agreed.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinate issue resolution using a risk-based approach.
• Review verification and validation reports and identify gaps for cGMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Provide consultation to end users and process owners regarding data collection, analysis and creation of validation reports.
• Identify areas and opportunities to improve design and development process.
• Ensure product development and validation programs meet requirements of FDA and ISO.
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Conduct quality audits of internal and external contractors.
• Management of incoming, in-process, and outgoing inspection of implants and instruments.
• Create routings and inspection documents for manufactured products.
• Create flowcharts and Standard Operating Procedures.
• Monitor quality & delivery performance.

Required Skills

• Ability to troubleshoot programming and production problems.
• The ability to advise the best inspection methods to the manufacturing floor and implement this same mindset onto our In Process Inspection Sheets.
• Experience with IdeaGen (Inspection Expert) and JobBoss² preferred.
• Must be proficient in the use of Microsoft Office products (Excel, Word, PowerPoint).
• Must be a critical thinker, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to new opportunities.
• Basic knowledge of FDA, GMP & ISO requirements & project management techniques.
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Highly effective communicator, able to act even when a position may be unpopular. Able to facilitate difficult conversations and negotiate solutions among different department representatives. Must be self-motivated and able to build consensus on projects.
• Strong customer service orientation.
• Minimum of 3 years' experience in the medical device industry or equivalent including knowledge of FDA, ISO13485 and GMP requirements.
• Lift 30 lbs.
• Work with limited supervision.
• Assist with any other duties as required.

Compensation very competitive with experience, excellent compensation and benefit package.

• Principals only. Recruiters, please don't contact this job poster.
• Do NOT contact us with unsolicited services or offers

Job Type: Full-time

Education and/or Experience

• Bachelor’s degree or equivalent, previous experience preferred

Language Skills

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

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

• Proficient in all Microsoft Office applications (Word, Excel, Outlook)

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus. Lifting/carrying up to 30lbs.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Additional Notes

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success.  All employees of ARCH Global Precision are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.